TriangleNCT02573259 · OUTCOME
Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2
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
- Baseline up to end of treatment (maximum of 851 days)
What was measured
Number of participants with ADA positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was ADA 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 ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were ADA positive at baseline but did not become boosted post-treatment were considered as ADA negative.
Analysis population: Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result.
Groups in this outcome
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
Part 2: PF-06801591 300 mg (SC) for NSCLC
Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
Part 2: PF-06801591 300 mg (SC) for UC
Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
Part 1: PF-06801591 1 mg/kg (IV)
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
Part 1: PF-06801591 3 mg/kg (IV)
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
Part 1: PF-06801591 10 mg/kg (IV)
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
| Group | Source count |
|---|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 14 |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | 64 |
| Part 2: PF-06801591 300 mg (SC) for UC | 37 |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
| Part 1: PF-06801591 1 mg/kg (IV) | 6 |
| Part 1: PF-06801591 3 mg/kg (IV) | 7 |
| Part 1: PF-06801591 10 mg/kg (IV) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: PF-06801591 300 mg (SC) for NSCLC | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2: PF-06801591 300 mg (SC) for UC | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 1 mg/kg (IV) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 3 mg/kg (IV) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 10 mg/kg (IV) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 37
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 6
- units
- Participants
- description
- Number of participants with ADA positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was ADA 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 ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were ADA positive at baseline but did not become boosted post-treatment were considered as ADA negative.
- groups
- description
- Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
- id
- OG000
- title
- Part 1: PF-06801591 300 mg (Subcutaneously [SC])
- description
- Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
- id
- OG001
- title
- Part 2: PF-06801591 300 mg (SC) for NSCLC
- description
- Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
- id
- OG002
- title
- Part 2: PF-06801591 300 mg (SC) for UC
- description
- Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
- id
- OG003
- title
- Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
- description
- Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
- id
- OG004
- title
- Part 1: PF-06801591 1 mg/kg (IV)
- description
- Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
- id
- OG005
- title
- Part 1: PF-06801591 3 mg/kg (IV)
- description
- Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
- id
- OG006
- title
- Part 1: PF-06801591 10 mg/kg (IV)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of treatment (maximum of 851 days)
- title
- Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice