TriangleNCT02598661 · OUTCOME
Phase 2 and Phase 3: Duration of RBC TI
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
What was measured
Duration of RBC TI was defined as the first day of the longest RBC TI period to the date of the first RBC transfusion after the TI period started. The 95% CI was based on Kaplan-Meier product limit estimates.
Analysis population: Phase 2: All Treated 8-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 8-week RBC TI. Phase 3: ITT 8-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 8-week RBC TI.
Groups in this outcome
Phase 2: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
Phase 3: Imetelstat Sodium
Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
Phase 3: Placebo
Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
| Group | Source count |
|---|---|
| Phase 2: Imetelstat Sodium | 21 |
| Phase 3: Imetelstat Sodium | 47 |
| Phase 3: Placebo | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Imetelstat Sodium | 69.6 | Not reported | 17.00 | 92.43 | Not reported |
| Phase 3: Imetelstat Sodium | 51.6 | Not reported | 26.86 | 80.43 | Not reported |
| Phase 3: Placebo | 13.3 | Not reported | 8.00 | 24.86 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.105
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.586
- estimate Comment
- Hazard ratio and 95% CI were calculated using the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- The p-value (2-sided) was calculated using the stratified log-rank test for superiority of imetelstat sodium versus placebo in hazard ratio.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.25
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.105
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.586
- estimate Comment
- Hazard ratio and 95% CI were calculated using the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- The p-value (2-sided) was calculated using the stratified log-rank test for superiority of imetelstat sodium versus placebo in hazard ratio.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.25
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.00
- upper Limit
- 92.43
- value
- 69.6
- group Id
- OG001
- lower Limit
- 26.86
- upper Limit
- 80.43
- value
- 51.6
- group Id
- OG002
- lower Limit
- 8.00
- upper Limit
- 24.86
- value
- 13.3
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 9
- units
- Participants
- description
- Duration of RBC TI was defined as the first day of the longest RBC TI period to the date of the first RBC transfusion after the TI period started. The 95% CI was based on Kaplan-Meier product limit estimates.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
- id
- OG000
- title
- Phase 2: Imetelstat Sodium
- description
- Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
- id
- OG001
- title
- Phase 3: Imetelstat Sodium
- description
- Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
- id
- OG002
- title
- Phase 3: Placebo
- param Type
- MEDIAN
- population Description
- Phase 2: All Treated 8-week TI Responder Analysis Set included participants in the All Treated Analysis Set who achieved 8-week RBC TI. Phase 3: ITT 8-week TI Responder Analysis Set included all participants in the ITT Analysis Set who achieved 8-week RBC TI.
- reporting Status
- POSTED
- time Frame
- Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
- title
- Phase 2 and Phase 3: Duration of RBC TI
- type
- SECONDARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice