NCT01292603 · OUTCOME
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia · Source last updated 2018-12-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants in the survey
- Interval / dispersion
- Not reported
- Time frame
- Days 4-5 in Cycle 6
What was measured
Physicians and nurses who administered rituximab were asked to answer the following question: " If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones)". The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.
Analysis population: All the physicians and nurses who responded to the questionnaire were included in the analysis.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 78 |
|---|
| Part 2: Rituximab SC 1600 mg | 81 |
|---|
Reported measurements
Nurse: 4 or more hours
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 21.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 21.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Nurse: At least 3 hours but less than 4 hours
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 23.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 29.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Nurse: At least 2 hours but less than 3 hours
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 26.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 23.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Nurse: At least 1 hour but less than 2 hours
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 17.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 11.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Nurse: Less than 1 hour
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 13.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 16.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: 4 or more hours
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 21.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 22.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: At least 3 hours but less than 4 hours
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 18.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 21.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: At least 2 hours but less than 3 hours
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 24.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 26.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: At least 1 hour but less than 2 hours
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 22.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 19.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Physician: Less than 1 hour
Values in percentage of participants in the survey · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 10.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: Rituximab SC 1600 mg | 7.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 21.0
- group Id
- OG001
- value
- 21.0
- title
- Nurse: 4 or more hours
- categories
- measurements
- group Id
- OG000
- value
- 23.0
- group Id
- OG001
- value
- 29.0
- title
- Nurse: At least 3 hours but less than 4 hours
- categories
- measurements
- group Id
- OG000
- value
- 26.0
- group Id
- OG001
- value
- 23.0
- title
- Nurse: At least 2 hours but less than 3 hours
- categories
- measurements
- group Id
- OG000
- value
- 17.0
- group Id
- OG001
- value
- 11.0
- title
- Nurse: At least 1 hour but less than 2 hours
- categories
- measurements
- group Id
- OG000
- value
- 13.0
- group Id
- OG001
- value
- 16.0
- title
- Nurse: Less than 1 hour
- categories
- measurements
- group Id
- OG000
- value
- 21.0
- group Id
- OG001
- value
- 22.0
- title
- Physician: 4 or more hours
- categories
- measurements
- group Id
- OG000
- value
- 18.0
- group Id
- OG001
- value
- 21.0
- title
- Physician: At least 3 hours but less than 4 hours
- categories
- measurements
- group Id
- OG000
- value
- 24.0
- group Id
- OG001
- value
- 26.0
- title
- Physician: At least 2 hours but less than 3 hours
- categories
- measurements
- group Id
- OG000
- value
- 22.0
- group Id
- OG001
- value
- 19.0
- title
- Physician: At least 1 hour but less than 2 hours
- categories
- measurements
- group Id
- OG000
- value
- 10.0
- group Id
- OG001
- value
- 7.0
- title
- Physician: Less than 1 hour
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 81
- units
- Participants
- description
- Physicians and nurses who administered rituximab were asked to answer the following question: " If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones)". The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.
- 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
- All the physicians and nurses who responded to the questionnaire were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Days 4-5 in Cycle 6
- title
- Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
- type
- SECONDARY
- unit Of Measure
- percentage of participants in the survey
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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