TriangleNCT01712789 · OUTCOME
Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
What was measured
Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.
Analysis population: The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.
Groups in this outcome
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
| Group | Source count |
|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 682 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide Plus Low Dose Dexamethasone (LD-Dex) | 4.6 | Not reported | 3.91 | 4.90 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.91
- upper Limit
- 4.90
- value
- 4.6
- denoms
- counts
- group Id
- OG000
- value
- 682
- units
- Participants
- description
- Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
- id
- OG000
- title
- Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
- param Type
- MEDIAN
- population Description
- The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.
- reporting Status
- POSTED
- time Frame
- From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
- title
- Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice