NCT00098475 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 223
- group Id
- BG001
- value
- 222
- group Id
- BG002
- value
- 445
- units
- Participants
- groups
- description
- Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles. As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
- id
- BG000
- title
- Arm I (Lenalidomide, Dexamethasone)
- description
- Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles. As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
- id
- BG001
- title
- Arm II (Lenalidomide, Low-dose Dexamethasone)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 36
- upper Limit
- 87
- value
- 66
- group Id
- BG001
- lower Limit
- 35
- upper Limit
- 85
- value
- 65
- group Id
- BG002
- lower Limit
- 35
- upper Limit
- 87
- value
- 65
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 91
- group Id
- BG001
- value
- 101
- group Id
- BG002
- value
- 192
- title
- Female
- measurements
- group Id
- BG000
- value
- 132
- group Id
- BG001
- value
- 121
- group Id
- BG002
- value
- 253
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 223
- group Id
- BG001
- value
- 222
- group Id
- BG002
- value
- 445
- units
- Participants
- groups
- description
- Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles. As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
- id
- BG000
- title
- Arm I (Lenalidomide, Dexamethasone)
- description
- Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles. As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
- id
- BG001
- title
- Arm II (Lenalidomide, Low-dose Dexamethasone)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 36
- upper Limit
- 87
- value
- 66
- group Id
- BG001
- lower Limit
- 35
- upper Limit
- 85
- value
- 65
- group Id
- BG002
- lower Limit
- 35
- upper Limit
- 87
- value
- 65
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 91
- group Id
- BG001
- value
- 101
- group Id
- BG002
- value
- 192
- title
- Female
- measurements
- group Id
- BG000
- value
- 132
- group Id
- BG001
- value
- 121
- group Id
- BG002
- value
- 253
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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