TriangleNCT02421939 · OUTCOME
Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of randomization up to at least 112 days
What was measured
The CR/CRh rate was defined as the number of participants who achieved either CR or CRh divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L and normal marrow differential with \< 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: Participants were classified as CRh if they had marrow blasts \< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\^9/L and platelets ≥ 50 x 10\^9/L, no evidence of extramedullary leukemia and could not be classified as CR.
Analysis population: The analysis population was the response analysis set (RAS) which consisted of participants who were who were at least 112 days past the first dose of gilteritinib or randomization (for participants who did not receive gilteritinib). The participants were analyzed based on the randomized treatments.
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.
| Group | Source count |
|---|---|
| Gilteritinib | 142 |
Reported measurements
CR/CRh rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gilteritinib | 28.2 | Not reported | 20.9 | 36.3 | Not reported |
CR rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gilteritinib | 19.0 | Not reported | 12.9 | 26.4 | Not reported |
CRh rate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gilteritinib | 9.2 | Not reported | 5.0 | 15.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.9
- upper Limit
- 36.3
- value
- 28.2
- title
- CR/CRh rate
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.9
- upper Limit
- 26.4
- value
- 19.0
- title
- CR rate
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.0
- upper Limit
- 15.1
- value
- 9.2
- title
- CRh rate
- denoms
- counts
- group Id
- OG000
- value
- 142
- units
- Participants
- description
- The CR/CRh rate was defined as the number of participants who achieved either CR or CRh divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L and normal marrow differential with \< 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: Participants were classified as CRh if they had marrow blasts \< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\^9/L and platelets ≥ 50 x 10\^9/L, no evidence of extramedullary leukemia and could not be classified as CR.
- 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
- param Type
- NUMBER
- population Description
- The analysis population was the response analysis set (RAS) which consisted of participants who were who were at least 112 days past the first dose of gilteritinib or randomization (for participants who did not receive gilteritinib). The participants were analyzed based on the randomized treatments.
- reporting Status
- POSTED
- time Frame
- From the date of randomization up to at least 112 days
- title
- Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice