NCT02421939 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation · Source last updated 2025-12-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days)
What was measured
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study drug, whether or not related to it. It could be any unfavorable/unintended sign (including abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of the study drug. A treatment-emergent adverse event (TEAE) : AEs observed after starting administration of study drug (gilteritinib or salvage chemotherapy). Serious AEs (SAEs): AEs which caused death, were life-threatening, resulted in persistent/significant disability/incapacity or disruption of the ability to conduct normal life functions, congenital anomaly, birth defect, required inpatient hospitalization/led to prolongation of hospitalization. Based on national cancer institute common terminology criteria (NCI-CTCAE), AEs were graded as grade 1=mild, grade 2=moderate, grade 3 =severe or medically significant, grade 4 =life threatening, grade 5 =death related to AE
Analysis population: The analysis population was the safety analysis set (SAF), which consisted of participants who received who received at least 1 dose of study drug (gilteritinib or salvage chemotherapy).
Groups in this outcome
Gilteritinib
Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
Salvage Chemotherapy
Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Gilteritinib | 246 |
|---|
| Salvage Chemotherapy | 109 |
|---|
Reported measurements
Drug-related TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 208 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 71 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 211 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug-related serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 92 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 76 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug-related TEAE leading to death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to withdrawal of treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 65 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug-related TEAE lead withdrawal of treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
NCI-CTCAE Grade 3 or higher TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 238 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 94 | Not reported | Not reported | Not reported | Not reported |
|---|
Drug-related Grade 3 or higher TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 157 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 57 | Not reported | Not reported | Not reported | Not reported |
|---|
Death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Gilteritinib | 203 | Not reported | Not reported | Not reported | Not reported |
|---|
| Salvage Chemotherapy | 87 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 208
- group Id
- OG001
- value
- 71
- title
- Drug-related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 211
- group Id
- OG001
- value
- 34
- title
- Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 16
- title
- Drug-related serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 16
- title
- TEAE leading to death
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 5
- title
- Drug-related TEAE leading to death
- categories
- measurements
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 13
- title
- TEAE leading to withdrawal of treatment
- categories
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 5
- title
- Drug-related TEAE lead withdrawal of treatment
- categories
- measurements
- group Id
- OG000
- value
- 238
- group Id
- OG001
- value
- 94
- title
- NCI-CTCAE Grade 3 or higher TEAE
- categories
- measurements
- group Id
- OG000
- value
- 157
- group Id
- OG001
- value
- 57
- title
- Drug-related Grade 3 or higher TEAE
- categories
- measurements
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 87
- title
- Death
- denoms
- counts
- group Id
- OG000
- value
- 246
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study drug, whether or not related to it. It could be any unfavorable/unintended sign (including abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of the study drug. A treatment-emergent adverse event (TEAE) : AEs observed after starting administration of study drug (gilteritinib or salvage chemotherapy). Serious AEs (SAEs): AEs which caused death, were life-threatening, resulted in persistent/significant disability/incapacity or disruption of the ability to conduct normal life functions, congenital anomaly, birth defect, required inpatient hospitalization/led to prolongation of hospitalization. Based on national cancer institute common terminology criteria (NCI-CTCAE), AEs were graded as grade 1=mild, grade 2=moderate, grade 3 =severe or medically significant, grade 4 =life threatening, grade 5 =death related to AE
- groups
- description
- Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
- id
- OG000
- title
- Gilteritinib
- description
- Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
- id
- OG001
- title
- Salvage Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis population was the safety analysis set (SAF), which consisted of participants who received who received at least 1 dose of study drug (gilteritinib or salvage chemotherapy).
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days)
- title
- Number of Participants With Treatment Emergent Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
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