Trial Outcomes & Findings for A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (NCT NCT01303796)
NCT ID: NCT01303796
Last Updated: 2022-06-22
Results Overview
The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
482 participants
Primary outcome timeframe
up to 43 months
Results posted on
2022-06-22
Participant Flow
The study comprised a single-arm Lead-in phase to confirm the safety and tolerability of administering sapacitabine in alternating cycles with decitabine prior to patients being enrolled in the parallel group, randomized Phase III phase to compare the two treatment arms. 21 patients were enrolled in the Lead-in phase.
Participant milestones
| Measure |
Lead In Phase
Decitabine alternating with sapacitabine (n=21). Patients followed for safety. Lead in group is not included in ITT analysis of randomized portion of the trial.
|
Sapacitabine-decitabine Alternating
Arm A patients received sapacitabine capsules in alternating cycles with decitabine i.e., Cycle 1=decitabine, Cycle 2=sapacitabine, Cycle 3=decitabine, Cycle 4=sapacitabine, etc. Arm A is preceded by a Lead-in phase in selected patients.
Sapacitabine: Oral capsules; 300 mg twice daily (b.i.d.) orally x 3 consecutive days/week x 2 weeks every 8 weeks Decitabine: Decitabine intravenous; 20 mg/m2 infused over 1 hour intravenously/day x 5 consecutive days every 8 weeks Patients continued treatment until one of the following occurred: clinically significant progressive disease; lack of efficacy; unacceptable toxicity; patient withdrawal of consent; investigator's assessment; intercurrent illness or changes in patient's condition that rendered the patient ineligible or continuing treatment unsafe, or regular follow-up impossible; a pattern of non-compliance with study medication or protocol-required evaluations and follow-up; or termination of the clinical trial by the sponsor.
|
Decitabine
Arm C patients received decitabine infusion.
Decitabine: Intravenous; 20 mg/m2 infused over 1 hour intravenously/day x 5 consecutive days every 8 weeks
Patients continued treatment until one of the following occurred: clinically significant progressive disease; lack of efficacy; unacceptable toxicity; patient withdrawal of consent; investigator's assessment that it was in the best interest of the patient to withdraw; intercurrent illness or changes in patient's condition that rendered the patient ineligible or continuing treatment unsafe, or regular follow-up impossible; a pattern of non-compliance with study medication or protocol-required evaluations and follow-up; or termination of the clinical trial by the sponsor.
|
|---|---|---|---|
|
Lead In Phase
STARTED
|
21
|
0
|
0
|
|
Lead In Phase
COMPLETED
|
21
|
0
|
0
|
|
Lead In Phase
NOT COMPLETED
|
0
|
0
|
0
|
|
Randomized Phase III
STARTED
|
0
|
241
|
241
|
|
Randomized Phase III
COMPLETED
|
0
|
241
|
241
|
|
Randomized Phase III
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Sapacitabine-decitabine Alternating
n=241 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=241 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
Total
n=482 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78 years
n=5 Participants
|
77 years
n=7 Participants
|
77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
212 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=226 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=218 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Overall Survival
|
5.9 Months
Interval 4.7 to 8.0
|
5.7 Months
Interval 4.9 to 8.2
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=241 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=241 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Complete Remission (CR)
Responders
|
40 Participants
|
26 Participants
|
|
Complete Remission (CR)
Non-Responders
|
198 Participants
|
213 Participants
|
|
Complete Remission (CR)
Missing
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=241 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=241 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Complete Remission With Incomplete Platelet Count Recovery (CRp)
Responders
|
5 Participants
|
5 Participants
|
|
Complete Remission With Incomplete Platelet Count Recovery (CRp)
Non-Responders
|
233 Participants
|
234 Participants
|
|
Complete Remission With Incomplete Platelet Count Recovery (CRp)
Missing
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=241 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=241 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Partial Remission (PR)
Responders
|
12 Participants
|
8 Participants
|
|
Partial Remission (PR)
Non-Responders
|
226 Participants
|
231 Participants
|
|
Partial Remission (PR)
Missing
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
HI with duration (HI) 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=241 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=241 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Hematological Improvement
Responders
|
41 Participants
|
38 Participants
|
|
Hematological Improvement
Non-Responders
|
197 Participants
|
201 Participants
|
|
Hematological Improvement
Missing
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=241 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=241 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Stable Disease (SD)
Responders
|
21 Participants
|
31 Participants
|
|
Stable Disease (SD)
Non-Responders
|
217 Participants
|
208 Participants
|
|
Stable Disease (SD)
Missing
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation.
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=236 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=233 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Blood Products Transfused
|
20 Pint
Interval 0.0 to 337.0
|
14 Pint
Interval 0.0 to 260.0
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
In-patient days in hospital.
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=236 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=233 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Hospitalized Days
|
15 Days
Interval 0.0 to 93.0
|
14 Days
Interval 0.0 to 172.0
|
SECONDARY outcome
Timeframe: Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage).Population: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function.
One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization.
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=241 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=241 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
1-year Survival
|
81 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Durations of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=40 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=26 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Duration of Complete Remission (dCR)
|
9.5 months
Interval 6.1 to 13.6
|
10.4 months
Interval 8.1 to 14.0
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Duration of normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=5 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=5 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)
|
9.5 months
Interval 3.1 to 20.7
|
5.7 months
Interval 3.0 to 12.5
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Duration of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=12 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=8 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Duration of Partial Remission (dPR)
|
2.2 months
Interval 1.2 to 9.9
|
1.9 months
Interval 0.5 to 9.8
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Duration of HI 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=41 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=38 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Duration of Hematological Improvement (dHI)
|
5.8 months
Interval 2.7 to 17.0
|
4.8 months
Interval 3.4 to 7.2
|
SECONDARY outcome
Timeframe: up to 43 monthsPopulation: Patients \>= 70 years with histologically or pathologically confirmed AML; not treated by systemic therapy; on low-intensity therapy by investigator assessment or the patient has refused standard induction chemotherapy; no prior treatment with HMA or other anti-cancer agents; ECOG status 0-2; adequate hepatic and renal function
Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.
Outcome measures
| Measure |
Sapacitabine-decitabine Alternating
n=21 Participants
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=31 Participants
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|
|
Duration of Stable Disease (dSD)
|
23.3 months
Interval 9.1 to 33.2
|
14.8 months
Interval 10.6 to
Data point not reported in final database. Insufficient number of participants with stable disease.
|
Adverse Events
Lead In Phase
Serious events: 17 serious events
Other events: 0 other events
Deaths: 21 deaths
Sapacitabine-decitabine Alternating
Serious events: 199 serious events
Other events: 236 other events
Deaths: 221 deaths
Decitabine
Serious events: 188 serious events
Other events: 232 other events
Deaths: 211 deaths
Serious adverse events
| Measure |
Lead In Phase
n=21 participants at risk
Sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
(n=21, not included in randomization)
|
Sapacitabine-decitabine Alternating
n=236 participants at risk
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=233 participants at risk
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|---|
|
Infections and infestations
PNEUMONIA
|
19.0%
4/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
23.7%
56/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
23.6%
55/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
21.6%
51/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
24.0%
56/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
9.5%
2/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.2%
10/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.0%
7/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.0%
7/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.3%
10/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.5%
6/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.6%
6/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.1%
5/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.1%
5/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.43%
1/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.1%
5/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.1%
5/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.00%
0/233 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
13.1%
31/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.2%
19/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
PYREXIA
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.2%
10/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.4%
8/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
SEPSIS
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
10.2%
24/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.9%
23/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
CELLULITIS
|
9.5%
2/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.2%
10/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.3%
10/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
PNEUMONIA FUNGAL
|
9.5%
2/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.4%
8/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.4%
8/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.5%
6/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.1%
5/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
BACTERAEMIA
|
14.3%
3/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.85%
2/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.6%
6/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.1%
5/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.00%
0/233 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Injury, poisoning and procedural complications
FALL
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.85%
2/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.43%
1/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.85%
2/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.43%
1/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.00%
0/236 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.86%
2/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.00%
0/233 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.5%
6/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.00%
0/233 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.86%
2/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Nervous system disorders
SYNCOPE
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.86%
2/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.6%
6/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.85%
2/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.43%
1/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.00%
0/236 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.86%
2/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
2.1%
5/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.86%
2/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.86%
2/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.43%
1/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.3%
3/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Vascular disorders
HYPERTENSION
|
4.8%
1/21 • Number of events 62 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.43%
1/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL
|
0.00%
0/21 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.42%
1/236 • Number of events 478 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
0.43%
1/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
Other adverse events
| Measure |
Lead In Phase
n=21 participants at risk
Sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
(n=21, not included in randomization)
|
Sapacitabine-decitabine Alternating
n=236 participants at risk
Arm A sapacitabine administered in alternating cycles with decitabine
Sapacitabine: Oral sapacitabine capsules
Decitabine: Decitabine intravenous
|
Decitabine
n=233 participants at risk
Arm C Decitabine
Decitabine: Decitabine intravenous
|
|---|---|---|---|
|
General disorders
FATIGUE
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
33.5%
79/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
30.9%
72/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
57.6%
136/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
55.4%
129/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
53.8%
127/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
51.1%
119/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
45.3%
107/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
37.8%
88/233 • Number of events 447 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
26.3%
62/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
26.6%
62/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
16.5%
39/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
11.6%
27/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.3%
22/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.2%
19/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.1%
12/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.2%
12/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.7%
23/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
10.7%
25/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.9%
14/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.6%
20/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
CONSTIPATION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
36.0%
85/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
43.3%
101/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
NAUSEA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
41.5%
98/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
34.3%
80/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
DIARRHOEA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
32.6%
77/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
25.3%
59/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
VOMITING
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
19.5%
46/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
16.7%
39/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
STOMATITIS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
15.3%
36/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.6%
20/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
13.1%
31/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.0%
21/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.7%
11/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.3%
17/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.8%
9/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.9%
16/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
OEDEMA PERIPHERAL
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
30.5%
72/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
27.9%
65/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
PYREXIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
19.9%
47/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
18.9%
44/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
ASTHENIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
21.6%
51/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
16.3%
38/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
DISEASE PROGRESSION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
13.6%
32/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.6%
20/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
PAIN
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.8%
16/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
CHILLS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.5%
13/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.4%
8/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.6%
13/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
PNEUMONIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
29.7%
70/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
29.6%
69/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
14.4%
34/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.4%
22/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
SEPSIS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
11.4%
27/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
10.3%
24/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
CELLULITIS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.2%
17/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.9%
23/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.3%
17/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.5%
13/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.9%
9/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.3%
22/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.9%
23/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Injury, poisoning and procedural complications
FALL
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.1%
19/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.6%
20/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Investigations
WEIGHT DECREASED
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
22.5%
53/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
21.9%
51/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Investigations
BLOOD CREATININE INCREASED
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
10.2%
24/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.9%
16/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.2%
17/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.4%
22/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.7%
11/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.6%
20/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.2%
10/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.3%
17/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
26.7%
63/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
23.2%
54/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
25.4%
60/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
21.9%
51/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
19.9%
47/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
17.6%
41/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
19.5%
46/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
17.6%
41/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
14.8%
35/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
16.3%
38/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
12.7%
30/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
14.2%
33/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
12.0%
28/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.6%
18/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.7%
18/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.9%
14/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.7%
18/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.8%
16/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.6%
13/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
16.1%
38/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
13.7%
32/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
11.0%
26/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
12.9%
30/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
11.4%
27/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
10.3%
24/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.6%
13/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.2%
10/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.6%
13/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Nervous system disorders
HEADACHE
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
16.5%
39/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
18.5%
43/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Nervous system disorders
DIZZINESS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
15.7%
37/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
13.3%
31/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Psychiatric disorders
INSOMNIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
12.3%
29/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
10.7%
25/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Psychiatric disorders
ANXIETY
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.1%
19/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.2%
19/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.9%
21/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Psychiatric disorders
DEPRESSION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.1%
12/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.3%
17/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Renal and urinary disorders
DYSURIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.1%
12/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Renal and urinary disorders
HAEMATURIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.4%
8/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
22.9%
54/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
21.0%
49/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
19.1%
45/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
21.5%
50/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
11.9%
28/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
12.4%
29/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.9%
21/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.2%
19/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
8.5%
20/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.9%
14/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.3%
10/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.1%
12/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
3.0%
7/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Skin and subcutaneous tissue disorders
RASH
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.2%
17/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
9.4%
22/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
13.6%
32/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
1.7%
4/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.6%
18/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.3%
17/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.3%
17/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.2%
17/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.0%
14/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
6.4%
15/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
5.6%
13/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Vascular disorders
HYPERTENSION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
12.7%
30/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
12.4%
29/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Vascular disorders
HYPOTENSION
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
7.6%
18/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
10.7%
25/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
|
Vascular disorders
HAEMATOMA
|
—
0/0 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.7%
11/236 • Number of events 4020 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
4.3%
10/233 • Number of events 3745 • Adverse event data were collected during the treatment period and in the post-treatment follow-up period (within 28 days after the last dose of study drug if possible or prior to the initiation of new anti-leukemia treatment, whichever comes first) up to 43 months.
The definitions of adverse event and serious adverse event are in congruence with clinicaltrials.gov standard definitions. Note: Other adverse events were not collected for the lead-in phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place