NCT01558921 · 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
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- groups
- description
- experimental group (arm B) M1 scheme M1 scheme: short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX
- id
- BG000
- title
- B: 5x5Gy -> CAPOX -> Surgery
- description
- control group (arm A) standard long course chemoradiotherapy standard long course chemoradiotherapy: long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.
- id
- BG001
- title
- A: 5 Weeks Chemoradiation -> Surgery
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 31
- upper Limit
- 83
- value
- 62
- group Id
- BG001
- lower Limit
- 23
- upper Limit
- 84
- value
- 62
- group Id
- BG002
- lower Limit
- 23
- upper Limit
- 84
- value
- 62
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 162
- group Id
- BG001
- value
- 138
- group Id
- BG002
- value
- 300
- title
- Female
- measurements
- group Id
- BG000
- value
- 300
- group Id
- BG001
- value
- 312
- group Id
- BG002
- value
- 612
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG002
- value
- 0
- denoms
- counts
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 180
- group Id
- BG001
- value
- 180
- group Id
- BG002
- value
- 360
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Netherlands
- categories
- measurements
- group Id
- BG000
- value
- 168
- group Id
- BG001
- value
- 160
- group Id
- BG002
- value
- 328
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Sweden
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 20
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 12
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 23
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Norway
- categories
- measurements
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 28
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Denmark
- categories
- measurements
- group Id
- BG000
- value
- 18
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 35
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Slovenia
- categories
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 60
- group Id
- BG002
- value
- 118
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Spain
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- population Description
- Eligible patients included in the overall study 468/920 were assigned to treatment B. 462/468 were eligible, 6/468 were ineligible 452/920 were assigned to treatment A. 450/452 were eligible, 9/452 were ineligible
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- groups
- description
- experimental group (arm B) M1 scheme M1 scheme: short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX
- id
- BG000
- title
- B: 5x5Gy -> CAPOX -> Surgery
- description
- control group (arm A) standard long course chemoradiotherapy standard long course chemoradiotherapy: long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.
- id
- BG001
- title
- A: 5 Weeks Chemoradiation -> Surgery
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 31
- upper Limit
- 83
- value
- 62
- group Id
- BG001
- lower Limit
- 23
- upper Limit
- 84
- value
- 62
- group Id
- BG002
- lower Limit
- 23
- upper Limit
- 84
- value
- 62
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 162
- group Id
- BG001
- value
- 138
- group Id
- BG002
- value
- 300
- title
- Female
- measurements
- group Id
- BG000
- value
- 300
- group Id
- BG001
- value
- 312
- group Id
- BG002
- value
- 612
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG002
- value
- 0
- denoms
- counts
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 180
- group Id
- BG001
- value
- 180
- group Id
- BG002
- value
- 360
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Netherlands
- categories
- measurements
- group Id
- BG000
- value
- 168
- group Id
- BG001
- value
- 160
- group Id
- BG002
- value
- 328
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Sweden
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 20
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 12
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 23
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Norway
- categories
- measurements
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 28
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Denmark
- categories
- measurements
- group Id
- BG000
- value
- 18
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 35
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Slovenia
- categories
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 60
- group Id
- BG002
- value
- 118
- denoms
- counts
- group Id
- BG000
- value
- 462
- group Id
- BG001
- value
- 450
- group Id
- BG002
- value
- 912
- units
- Participants
- title
- Spain
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- population Description
- Eligible patients included in the overall study 468/920 were assigned to treatment B. 462/468 were eligible, 6/468 were ineligible 452/920 were assigned to treatment A. 450/452 were eligible, 9/452 were ineligible
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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