TriangleNCT01088984 · OUTCOME
Overall Response Rate (ORR)
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
- Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles
What was measured
ORR was calculated as follows: number of participants in the primary analysis set achieving a best overall response of complete remission without platelet recovery (CRp) or complete remission (CR), divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A CR required no evidence of circulating blasts or extramedullary disease, an M1 marrow (≤ 5% bone marrow blasts), and recovery of peripheral counts (platelets ≥ 100 × 10\^9/L and absolute neutrophil count ≥ 1.0 × 10\^9/L). A CR without platelet recovery (CRp) required all of the criteria for a CR with the exception of platelet recovery.
Analysis population: The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.
Groups in this outcome
Phase 2: Bendamustine 120 mg/m^2
Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
| Group | Source count |
|---|---|
| Phase 2: Bendamustine 120 mg/m^2 | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Bendamustine 120 mg/m^2 | 0 | Not reported | 0.00 | NA | 1-sided 95% confidence interval |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 1.0000
- p Value Comment
- 1-sided p-value is calculated against the null hypothesis of a response rate of 5%.
- statistical Method
- binomial parameter exact method
- tested Non Inferiority
- false
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 1.0000
- p Value Comment
- 1-sided p-value is calculated against the null hypothesis of a response rate of 5%.
- statistical Method
- binomial parameter exact method
- tested Non Inferiority
- false
- classes
- categories
- measurements
- comment
- 1-sided 95% confidence interval
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 32
- units
- Participants
- description
- ORR was calculated as follows: number of participants in the primary analysis set achieving a best overall response of complete remission without platelet recovery (CRp) or complete remission (CR), divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A CR required no evidence of circulating blasts or extramedullary disease, an M1 marrow (≤ 5% bone marrow blasts), and recovery of peripheral counts (platelets ≥ 100 × 10\^9/L and absolute neutrophil count ≥ 1.0 × 10\^9/L). A CR without platelet recovery (CRp) required all of the criteria for a CR with the exception of platelet recovery.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
- id
- OG000
- title
- Phase 2: Bendamustine 120 mg/m^2
- param Type
- NUMBER
- population Description
- The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.
- reporting Status
- POSTED
- time Frame
- Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles
- title
- Overall Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice