TriangleNCT02598661 · OUTCOME
Phase 2 and Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 24-Weeks Period
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
- Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
What was measured
Percentage of participants without any RBC transfusion during any consecutive 24 weeks (168 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2 and the day of randomization for participants enrolled in Phase 3. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.
Analysis population: Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.
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 | 57 |
| Phase 3: Imetelstat Sodium | 118 |
| Phase 3: Placebo | 60 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Imetelstat Sodium | 24.6 | Not reported | 14.13 | 37.76 | Not reported |
| Phase 3: Imetelstat Sodium | 28.0 | Not reported | 20.10 | 36.98 | Not reported |
| Phase 3: Placebo | 3.3 | Not reported | 0.41 | 11.53 | Not reported |
Source statistical analyses
- ci Lower Limit
- 12.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 34.18
- estimate Comment
- The 95% CI was calculated based on the Wilson Score method.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.
- param Type
- Percentage Difference
- param Value
- 24.6
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 12.64
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 34.18
- estimate Comment
- The 95% CI was calculated based on the Wilson Score method.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.
- param Type
- Percentage Difference
- param Value
- 24.6
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.13
- upper Limit
- 37.76
- value
- 24.6
- group Id
- OG001
- lower Limit
- 20.10
- upper Limit
- 36.98
- value
- 28.0
- group Id
- OG002
- lower Limit
- 0.41
- upper Limit
- 11.53
- value
- 3.3
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 118
- group Id
- OG002
- value
- 60
- units
- Participants
- description
- Percentage of participants without any RBC transfusion during any consecutive 24 weeks (168 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2 and the day of randomization for participants enrolled in Phase 3. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.
- 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
- NUMBER
- population Description
- Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: ITT Analysis Set included all participants randomized into the Phase 3 study.
- 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: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 24-Weeks Period
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice