TriangleNCT02421939 · OUTCOME
Duration of Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to until the date of death from any cause (median time of follow-up for OS was 17.8 months)
What was measured
Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive. The last contact date was derived for participants alive at the analysis cutoff date. Survival rate and 95% CI were estimated using the Kaplan-Meier method and the Greenwood formula.
Analysis population: The analysis population was the Intention to Treatment (ITT) which consisted of all randomized participants.
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 | Source count |
|---|---|
| Gilteritinib | 247 |
| Salvage Chemotherapy | 124 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gilteritinib | 9.3 | Not reported | 7.7 | 10.7 | Not reported |
| Salvage Chemotherapy | 5.6 | Not reported | 4.7 | 7.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.490
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.830
- estimate Comment
- Based on Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm
- group Description
- Stratified analysis where tratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0004
- p Value Comment
- 1-sided P-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.637
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.490
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.830
- estimate Comment
- Based on Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm
- group Description
- Stratified analysis where tratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0004
- p Value Comment
- 1-sided P-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.637
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.7
- upper Limit
- 10.7
- value
- 9.3
- group Id
- OG001
- lower Limit
- 4.7
- upper Limit
- 7.3
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 247
- group Id
- OG001
- value
- 124
- units
- Participants
- description
- Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive. The last contact date was derived for participants alive at the analysis cutoff date. Survival rate and 95% CI were estimated using the Kaplan-Meier method and the Greenwood formula.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- The analysis population was the Intention to Treatment (ITT) which consisted of all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization to until the date of death from any cause (median time of follow-up for OS was 17.8 months)
- title
- Duration of Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice