TriangleNCT02598661 · OUTCOME
Phase 2 and Phase 3: Amount of RBC Transfusions in the Best 8-week Interval
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- number of RBC transfusions units
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
What was measured
Amount of RBC transfusions for 8-week interval was defined as the total number of RBC transfusion units in a given 8-week interval during study. The best 8-week interval is a post-baseline 8-week interval where the participant had the fewest post-Study Day 1 RBC transfusion units. A valid 8-week period must start before the date of last dose of study drug + 30 days or end of treatment (EOT) visit whichever occurs first and ends before the first transfusion in post-treatment follow-up or the first day of subsequent anti-cancer therapy whichever occurs first.
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 | 3.0 | 3.48 | Not reported | Not reported | Not reported |
| Phase 3: Imetelstat Sodium | 3.1 | 3.62 | Not reported | Not reported | Not reported |
| Phase 3: Placebo | 3.4 | 2.13 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.48
- value
- 3.0
- group Id
- OG001
- spread
- 3.62
- value
- 3.1
- group Id
- OG002
- spread
- 2.13
- value
- 3.4
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 118
- group Id
- OG002
- value
- 60
- units
- Participants
- description
- Amount of RBC transfusions for 8-week interval was defined as the total number of RBC transfusion units in a given 8-week interval during study. The best 8-week interval is a post-baseline 8-week interval where the participant had the fewest post-Study Day 1 RBC transfusion units. A valid 8-week period must start before the date of last dose of study drug + 30 days or end of treatment (EOT) visit whichever occurs first and ends before the first transfusion in post-treatment follow-up or the first day of subsequent anti-cancer therapy whichever occurs first.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- 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: Amount of RBC Transfusions in the Best 8-week Interval
- type
- SECONDARY
- unit Of Measure
- number of RBC transfusions units
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice