TriangleNCT01292603 · OUTCOME
Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants or nurses
- Interval / dispersion
- Not reported
- Time frame
- Days 4 to 5 in Cycle 6
What was measured
In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC
Analysis population: All participants in Part 1 were included in this analysis including 8 participants that did not receive SC rituximab.
Groups in this outcome
Part 1: Rituximab SC 1400 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to 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 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).
Part 1: Rituximab SC 1600 mg
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 1600 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 1: Rituximab SC 1870 mg
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 1870 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 1400 mg | 16 |
| Part 1: Rituximab SC 1600 mg | 17 |
| Part 1: Rituximab SC 1870 mg | 23 |
Reported measurements
Participants who preferred SC
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Rituximab SC 1400 mg | 88.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Rituximab SC 1600 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Rituximab SC 1870 mg | 91.0 | Not reported | Not reported | Not reported | Not reported |
Participants who preferred IV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Rituximab SC 1400 mg | 13.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Rituximab SC 1600 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Rituximab SC 1870 mg | 9.0 | Not reported | Not reported | Not reported | Not reported |
Nurses who preferred SC
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Rituximab SC 1400 mg | 88.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Rituximab SC 1600 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Rituximab SC 1870 mg | 91.0 | Not reported | Not reported | Not reported | Not reported |
Nurses who preferred IV
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Rituximab SC 1400 mg | 13.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Rituximab SC 1600 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Rituximab SC 1870 mg | 9.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 88.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 91.0
- title
- Participants who preferred SC
- categories
- measurements
- group Id
- OG000
- value
- 13.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 9.0
- title
- Participants who preferred IV
- categories
- measurements
- group Id
- OG000
- value
- 88.0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 91.0
- title
- Nurses who preferred SC
- categories
- measurements
- group Id
- OG000
- value
- 13.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 9.0
- title
- Nurses who preferred IV
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 23
- units
- Participants
- description
- In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC
- groups
- description
- Participant could have been enrolled any time during treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to 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 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 1400 mg
- 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 1600 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 1: Rituximab SC 1600 mg
- 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 1870 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
- OG002
- title
- Part 1: Rituximab SC 1870 mg
- param Type
- NUMBER
- population Description
- All participants in Part 1 were included in this analysis including 8 participants that did not receive SC rituximab.
- reporting Status
- POSTED
- time Frame
- Days 4 to 5 in Cycle 6
- title
- Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration
- type
- SECONDARY
- unit Of Measure
- percentage of participants or nurses
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice