TriangleNCT01495598 · OUTCOME
Progression Free Survival (PFS)
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
- time from day 1 of pomalidomide therapy until progression requiring a change in therapy, an average of 9.97 months
What was measured
PFS is defined as time from day 1 of pomalidomide therapy until progression requiring a change in therapy, estimated using the Kaplan-Meier method. Progression was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.
Groups in this outcome
All Participants
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
HIV Positive Participants
HIV positive participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
HIV Negative Participants
HIV negative participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
| Group | Source count |
|---|---|
| All Participants | 28 |
| HIV Positive Participants | 18 |
| HIV Negative Participants | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 10.2 | Not reported | 7.6 | 15.7 | Not reported |
| HIV Positive Participants | 10.3 | Not reported | 4.8 | 21.9 | Not reported |
| HIV Negative Participants | 9.4 | Not reported | 6.0 | 26.0 | Not reported |
Source statistical analyses
- group Ids
- OG001
- OG002
- non Inferiority Comment
- Other = Kaplan Meier
- non Inferiority Type
- OTHER
- p Value
- 0.43
- statistical Method
- Log Rank
Complete source fields
- analyses
- group Ids
- OG001
- OG002
- non Inferiority Comment
- Other = Kaplan Meier
- non Inferiority Type
- OTHER
- p Value
- 0.43
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.6
- upper Limit
- 15.7
- value
- 10.2
- group Id
- OG001
- lower Limit
- 4.8
- upper Limit
- 21.9
- value
- 10.3
- group Id
- OG002
- lower Limit
- 6.0
- upper Limit
- 26.0
- value
- 9.4
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- PFS is defined as time from day 1 of pomalidomide therapy until progression requiring a change in therapy, estimated using the Kaplan-Meier method. Progression was assessed using the Modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group criteria. Progressive disease (PD) involved a 25% or greater increase in total lesions, nodular lesion, or area of the five indicator lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
- id
- OG000
- title
- All Participants
- description
- HIV positive participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
- id
- OG001
- title
- HIV Positive Participants
- description
- HIV negative participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
- id
- OG002
- title
- HIV Negative Participants
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- time from day 1 of pomalidomide therapy until progression requiring a change in therapy, an average of 9.97 months
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice