NCT01625234 · 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
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 94
- group Id
- BG007
- value
- 131
- units
- Participants
- groups
- description
- Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG000
- title
- Phase I: X-396 (Ensartinib) 25 mg
- description
- Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG001
- title
- Phase I: X-396 (Ensartinib) 50 mg
- description
- Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG002
- title
- Phase I: X-396 (Ensartinib) 100 mg
- description
- Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG003
- title
- Phase I: X-396 (Ensartinib) 200 mg
- description
- Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG004
- title
- Phase I: X-396 (Ensartinib) 225 mg
- description
- Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG005
- title
- Phase I: X-396 (Ensartinib) 250 mg
- description
- Dose exxpansion at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase II: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG006
- title
- Phase II: X-396 (Ensartinib) 225 mg
- description
- Total of all reporting groups
- id
- BG007
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 94
- group Id
- BG007
- value
- 131
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 7.33
- value
- 53.5
- group Id
- BG001
- spread
- 16.20
- value
- 57.7
- group Id
- BG002
- spread
- 4.87
- value
- 56.2
- group Id
- BG003
- spread
- 14.05
- value
- 57.5
- group Id
- BG004
- spread
- 12.25
- value
- 60.0
- group Id
- BG005
- spread
- 11.58
- value
- 55.4
- group Id
- BG006
- spread
- 13.59
- value
- 56.0
- group Id
- BG007
- spread
- 12.92
- value
- 56.2
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 46
- group Id
- BG007
- value
- 64
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 48
- group Id
- BG007
- value
- 67
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 2
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 18
- group Id
- BG007
- value
- 19
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 4
- group Id
- BG007
- value
- 7
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 65
- group Id
- BG007
- value
- 98
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 1
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 4
- group Id
- BG007
- value
- 4
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 94
- group Id
- BG007
- value
- 131
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 29
- group Id
- BG007
- value
- 45
- title
- 0
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 63
- group Id
- BG007
- value
- 84
- title
- 1
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 1
- title
- 2
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 1
- title
- Not Determined
- description
- The ECOG (Eastern Cooperative Oncology Group) Performance Status is a scale 0: Fully active, normal 1. Symptomatic but completely ambulatory and able to carry out light-housework and sedentary activities 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. Dead
- param Type
- NUMBER
- title
- ECOG Performance Status
- unit Of Measure
- # of patients with Score Grade (0-5)
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 8
- group Id
- BG006
- value
- 57
- group Id
- BG007
- value
- 78
- title
- Never
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 36
- group Id
- BG007
- value
- 49
- title
- Former
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 4
- title
- Current
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Tobacco user
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 94
- group Id
- BG007
- value
- 131
- units
- Participants
- groups
- description
- Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG000
- title
- Phase I: X-396 (Ensartinib) 25 mg
- description
- Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG001
- title
- Phase I: X-396 (Ensartinib) 50 mg
- description
- Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG002
- title
- Phase I: X-396 (Ensartinib) 100 mg
- description
- Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG003
- title
- Phase I: X-396 (Ensartinib) 200 mg
- description
- Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG004
- title
- Phase I: X-396 (Ensartinib) 225 mg
- description
- Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG005
- title
- Phase I: X-396 (Ensartinib) 250 mg
- description
- Dose exxpansion at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase II: X-396 (ensartinib): Oral, ALK inhibitor
- id
- BG006
- title
- Phase II: X-396 (Ensartinib) 225 mg
- description
- Total of all reporting groups
- id
- BG007
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 94
- group Id
- BG007
- value
- 131
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 7.33
- value
- 53.5
- group Id
- BG001
- spread
- 16.20
- value
- 57.7
- group Id
- BG002
- spread
- 4.87
- value
- 56.2
- group Id
- BG003
- spread
- 14.05
- value
- 57.5
- group Id
- BG004
- spread
- 12.25
- value
- 60.0
- group Id
- BG005
- spread
- 11.58
- value
- 55.4
- group Id
- BG006
- spread
- 13.59
- value
- 56.0
- group Id
- BG007
- spread
- 12.92
- value
- 56.2
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 46
- group Id
- BG007
- value
- 64
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 48
- group Id
- BG007
- value
- 67
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 2
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 18
- group Id
- BG007
- value
- 19
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 4
- group Id
- BG007
- value
- 7
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 65
- group Id
- BG007
- value
- 98
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 1
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 4
- group Id
- BG007
- value
- 4
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 10
- group Id
- BG006
- value
- 94
- group Id
- BG007
- value
- 131
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 4
- group Id
- BG006
- value
- 29
- group Id
- BG007
- value
- 45
- title
- 0
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 63
- group Id
- BG007
- value
- 84
- title
- 1
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 1
- title
- 2
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 1
- title
- Not Determined
- description
- The ECOG (Eastern Cooperative Oncology Group) Performance Status is a scale 0: Fully active, normal 1. Symptomatic but completely ambulatory and able to carry out light-housework and sedentary activities 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. Dead
- param Type
- NUMBER
- title
- ECOG Performance Status
- unit Of Measure
- # of patients with Score Grade (0-5)
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 8
- group Id
- BG006
- value
- 57
- group Id
- BG007
- value
- 78
- title
- Never
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 36
- group Id
- BG007
- value
- 49
- title
- Former
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 4
- title
- Current
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Tobacco user
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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