TriangleNCT02257567 · OUTCOME
Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From Month 37 to Month 84 (up to approximately 47 months)
What was measured
The number of participants with positive results for ADA against lyophilized pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.
Analysis population: Safety population consisted of all ITT participants from Arm G+H (Phase II NF cohort) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.
Groups in this outcome
Arm G (Phase II NF Cohort): Pola+BR in DLBCL
Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
Arm H (Phase II NF Cohort): Pola+BR in DLBCL
Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
| Group | Source count |
|---|---|
| Arm G (Phase II NF Cohort): Pola+BR in DLBCL | 41 |
| Arm H (Phase II NF Cohort): Pola+BR in DLBCL | 62 |
Reported measurements
Baseline Prevalence of ADAs to Polatuzumab
| Group | Source count |
|---|---|
| Arm G (Phase II NF Cohort): Pola+BR in DLBCL | 41 |
| Arm H (Phase II NF Cohort): Pola+BR in DLBCL | 62 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm G (Phase II NF Cohort): Pola+BR in DLBCL | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Arm H (Phase II NF Cohort): Pola+BR in DLBCL | 1.6 | Not reported | Not reported | Not reported | Not reported |
Post-Baseline Incidence of ADAs to Polatuzumab
| Group | Source count |
|---|---|
| Arm G (Phase II NF Cohort): Pola+BR in DLBCL | 39 |
| Arm H (Phase II NF Cohort): Pola+BR in DLBCL | 60 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm G (Phase II NF Cohort): Pola+BR in DLBCL | 2.6 | Not reported | Not reported | Not reported | Not reported |
| Arm H (Phase II NF Cohort): Pola+BR in DLBCL | 5.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 1.6
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 62
- units
- Participants
- title
- Baseline Prevalence of ADAs to Polatuzumab
- categories
- measurements
- group Id
- OG000
- value
- 2.6
- group Id
- OG001
- value
- 5.0
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 60
- units
- Participants
- title
- Post-Baseline Incidence of ADAs to Polatuzumab
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- The number of participants with positive results for ADA against lyophilized pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.
- groups
- description
- Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
- id
- OG000
- title
- Arm G (Phase II NF Cohort): Pola+BR in DLBCL
- description
- Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
- id
- OG001
- title
- Arm H (Phase II NF Cohort): Pola+BR in DLBCL
- param Type
- NUMBER
- population Description
- Safety population consisted of all ITT participants from Arm G+H (Phase II NF cohort) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.
- reporting Status
- POSTED
- time Frame
- From Month 37 to Month 84 (up to approximately 47 months)
- title
- Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice