TriangleNCT01292603 · OUTCOME
Part 1: 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
- Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose
What was measured
Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.
Analysis population: Safety Analysis Population (SAP): all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. This included 8 participants that did not receive SC rituximab. n = number of participants analyzed.
Groups in this outcome
Part 1: Rituximab SC
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 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 1: Rituximab SC | 64 |
Reported measurements
Pre-Dose Cycle 5: positive for HACAs (n=59)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Rituximab SC | 0.0 | Not reported | Not reported | Not reported | Not reported |
Pre-Dose Cycle 5: negative for HACAs (n=59)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Rituximab SC | 100.0 | Not reported | Not reported | Not reported | Not reported |
Post-Dose: positive for HACAs (n=61)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Rituximab SC | 5.0 | Not reported | Not reported | Not reported | Not reported |
Post-Dose: negative for HACAs (n=61)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Rituximab SC | 95.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- title
- Pre-Dose Cycle 5: positive for HACAs (n=59)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- title
- Pre-Dose Cycle 5: negative for HACAs (n=59)
- categories
- measurements
- group Id
- OG000
- value
- 5.0
- title
- Post-Dose: positive for HACAs (n=61)
- categories
- measurements
- group Id
- OG000
- value
- 95.1
- title
- Post-Dose: negative for HACAs (n=61)
- denoms
- counts
- group Id
- OG000
- value
- 64
- units
- Participants
- description
- Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.
- groups
- description
- Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 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
- OG000
- title
- Part 1: Rituximab SC
- param Type
- NUMBER
- population Description
- Safety Analysis Population (SAP): all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. This included 8 participants that did not receive SC rituximab. n = number of participants analyzed.
- reporting Status
- POSTED
- time Frame
- Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose
- title
- Part 1: 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