TriangleNCT01292603 · OUTCOME
Part 2: Percentage of Participants With Anti-Rituximab Antibodies
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
- Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.
What was measured
In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.
Analysis population: SAP; n = number of participants analyzed for the specific parameter.
Groups in this outcome
Part 2 : Rituximab IV 500 mg/m^2
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
Part 2: Rituximab SC 1600 mg
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
| Group | Source count |
|---|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 89 |
| Part 2: Rituximab SC 1600 mg | 85 |
Reported measurements
Baseline pre Cycle 1: positive for HACAs (n=87,85)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Rituximab SC 1600 mg | 2.4 | Not reported | Not reported | Not reported | Not reported |
Baseline pre Cycle 1: negative for HACAs (n=87,85)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Rituximab SC 1600 mg | 97.6 | Not reported | Not reported | Not reported | Not reported |
Post-Baseline: positive for HACAs (n=89,85)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 15.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Rituximab SC 1600 mg | 12.0 | Not reported | Not reported | Not reported | Not reported |
Post-Baseline: negative for HACAs (n=89,85)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 85.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Rituximab SC 1600 mg | 88.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 2.4
- title
- Baseline pre Cycle 1: positive for HACAs (n=87,85)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 97.6
- title
- Baseline pre Cycle 1: negative for HACAs (n=87,85)
- categories
- measurements
- group Id
- OG000
- value
- 15.0
- group Id
- OG001
- value
- 12.0
- title
- Post-Baseline: positive for HACAs (n=89,85)
- categories
- measurements
- group Id
- OG000
- value
- 85.0
- group Id
- OG001
- value
- 88.0
- title
- Post-Baseline: negative for HACAs (n=89,85)
- denoms
- counts
- group Id
- OG000
- value
- 89
- group Id
- OG001
- value
- 85
- units
- Participants
- description
- In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.
- groups
- description
- Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
- id
- OG000
- title
- Part 2 : Rituximab IV 500 mg/m^2
- description
- Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
- id
- OG001
- title
- Part 2: Rituximab SC 1600 mg
- param Type
- NUMBER
- population Description
- SAP; n = number of participants analyzed for the specific parameter.
- reporting Status
- POSTED
- time Frame
- Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.
- title
- Part 2: Percentage of Participants With Anti-Rituximab Antibodies
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice