TriangleNCT02580058 · OUTCOME
Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)
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
- At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab
What was measured
Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.
Analysis population: The analysis set was defined as participants with at least 1 valid post-baseline ADA result and without positive baseline nAb result in the immunogenicity analysis set. The immunogenicity analysis set was a subset of the safety analysis set and included patients who had at least one ADA/nAb sample collected for avelumab in the avelumab containing arms.
Groups in this outcome
Avelumab
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab + PLD
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
All Participants
Total participants from the 2 arms.
| Group | Source count |
|---|---|
| Avelumab | 173 |
| Avelumab + PLD | 169 |
| All Participants | 342 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab | 5 | Not reported | Not reported | Not reported | Not reported |
| Avelumab + PLD | 1 | Not reported | Not reported | Not reported | Not reported |
| All Participants | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 173
- group Id
- OG001
- value
- 169
- group Id
- OG002
- value
- 342
- units
- Participants
- description
- Treatment-induced nAb was defined as participant who was not nAb positive at baseline and had at least one positive post-baseline nAb result; or if participant did not have a baseline sample, the participant had at least one positive past-baseline ADA result.
- groups
- description
- Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
- id
- OG000
- title
- Avelumab
- description
- Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
- id
- OG001
- title
- Avelumab + PLD
- description
- Total participants from the 2 arms.
- id
- OG002
- title
- All Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis set was defined as participants with at least 1 valid post-baseline ADA result and without positive baseline nAb result in the immunogenicity analysis set. The immunogenicity analysis set was a subset of the safety analysis set and included patients who had at least one ADA/nAb sample collected for avelumab in the avelumab containing arms.
- reporting Status
- POSTED
- time Frame
- At predose (0 H) of select cycles starting from Cycle 1 through Cycle 24, at end of treatment and 30 days after the last dose of avelumab
- title
- Number of Participants With Treatment-Induced Neutralizing Antibody (nAb)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice