NCT01049945 · 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
- 15
- group Id
- BG001
- value
- 55
- group Id
- BG002
- value
- 70
- units
- Participants
- groups
- description
- Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
- id
- BG000
- title
- Phase I
- description
- Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
- id
- BG001
- title
- Maximum Tolerated Dose, Dose Level 4
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 41.8
- upper Limit
- 75.0
- value
- 63.5
- group Id
- BG001
- lower Limit
- 40.1
- upper Limit
- 86.3
- value
- 61.9
- group Id
- BG002
- lower Limit
- 40.1
- upper Limit
- 86.3
- value
- 62.3
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 27
- group Id
- BG002
- value
- 30
- title
- Female
- measurements
- group Id
- BG000
- value
- 12
- group Id
- BG001
- value
- 28
- group Id
- BG002
- value
- 40
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 55
- group Id
- BG002
- value
- 70
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 55
- group Id
- BG002
- value
- 70
- units
- Participants
- groups
- description
- Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
- id
- BG000
- title
- Phase I
- description
- Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
- id
- BG001
- title
- Maximum Tolerated Dose, Dose Level 4
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 41.8
- upper Limit
- 75.0
- value
- 63.5
- group Id
- BG001
- lower Limit
- 40.1
- upper Limit
- 86.3
- value
- 61.9
- group Id
- BG002
- lower Limit
- 40.1
- upper Limit
- 86.3
- value
- 62.3
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 27
- group Id
- BG002
- value
- 30
- title
- Female
- measurements
- group Id
- BG000
- value
- 12
- group Id
- BG001
- value
- 28
- group Id
- BG002
- value
- 40
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 55
- group Id
- BG002
- value
- 70
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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