NCT02598661 · OUTCOME
Phase 2 and Phase 3: Percentage of Participants Who Received Any Myeloid Growth Factors
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
- Not reported
- Time frame
- Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
What was measured
Percentage of participants who received any myeloid growth factors starting from Study Day 1 were reported. 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 | 33 | Not reported | Not reported | Not reported | Not reported |
| Phase 3: Imetelstat Sodium | 35.6 | Not reported | Not reported | Not reported | Not reported |
| Phase 3: Placebo | 5.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 35.6
- group Id
- OG002
- value
- 5.0
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 118
- group Id
- OG002
- value
- 60
- units
- Participants
- description
- Percentage of participants who received any myeloid growth factors starting from Study Day 1 were reported. Percentages were rounded off to the nearest single decimal place.
- 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 Who Received Any Myeloid Growth Factors
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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