TriangleNCT03269136 · OUTCOME
Part 2: Number of Participants With ADA and NAb Against PF-06863135
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 34.3 months)
What was measured
Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).
Analysis population: The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected.
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
ADA positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 0 | Not reported | Not reported | Not reported | Not reported |
NAb positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: PF-06863135 SC | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- ADA positive
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- NAb positive
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- Number of participants with ADA and NAb against PF-06863135 were reported in this outcome measure. A participant was ADA (or NAb) positive if: (1) baseline titer was missing or negative and participant had \>= 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \>= 4-folder dilution increase in titer from baseline in \>= 1 post-treatment sample (treatment-boosted).
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- The immunogenicity analysis set was defined as participants who received at least 1 dose of study treatment and have at least 1 ADA sample collected.
- reporting Status
- POSTED
- time Frame
- From first dose of the study treatment (Day 1) up to end of study treatment (maximum up to 34.3 months)
- title
- Part 2: Number of Participants With ADA and NAb Against PF-06863135
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice