NCT03269136 · OUTCOME
Part 2: OS
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 start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 34.3 months)
What was measured
OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.
Analysis population: mITT analysis set included all participants who have received at least one dose of study treatment.
Groups in this outcome
Part 2A: PF-06863135 SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
| Group | Source count |
|---|---|
| Part 2A: PF-06863135 SC | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 12.1 | Not reported | 4.2 | NA | Upper limit of 95% CI was not estimable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- NA
- value
- 12.1
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- OS was defined as the time from start date of study treatment to date of death due to any cause. OS for participants not known to had died were censored on the date of last known alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 44 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 76 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG000
- title
- Part 2A: PF-06863135 SC
- param Type
- MEDIAN
- population Description
- mITT analysis set included all participants who have received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Time from start date of study treatment to date of death due to any cause or last-known-alive date, whichever occurred first (maximum up to 34.3 months)
- title
- Part 2: OS
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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