NCT02888743 · 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
- 26
- group Id
- BG001
- value
- 26
- group Id
- BG002
- value
- 26
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 97
- units
- Participants
- groups
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- BG000
- title
- NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- BG001
- title
- NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
- id
- BG002
- title
- NSCLC Arm C (Tremelimumab, Durvalumab)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- BG003
- title
- CRC Arm A Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- BG004
- title
- CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 46.0
- upper Limit
- 88.0
- value
- 65.5
- group Id
- BG001
- lower Limit
- 45.0
- upper Limit
- 77.0
- value
- 68.0
- group Id
- BG002
- lower Limit
- 29.0
- upper Limit
- 77.0
- value
- 65.5
- group Id
- BG003
- lower Limit
- 38
- upper Limit
- 79
- value
- 58
- group Id
- BG004
- lower Limit
- 29
- upper Limit
- 77
- value
- 59
- group Id
- BG005
- lower Limit
- 29.0
- upper Limit
- 88.0
- value
- 66.0
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 39
- title
- Female
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 58
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 6
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 25
- group Id
- BG002
- value
- 25
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 88
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- 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
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 4
- 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
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 8
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 22
- group Id
- BG002
- value
- 21
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 78
- 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
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 7
- 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
- 26
- group Id
- BG001
- value
- 26
- group Id
- BG002
- value
- 26
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 97
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 31
- title
- 0 (Fully active)
- measurements
- group Id
- BG000
- value
- 19
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 64
- title
- 1 (Restricted in strenuous activities)
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- title
- 2 (Restricted in work; capable of self care)
- description
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS) scale measures a patient's functional status in relation to cancer. The scale describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. Scoring is as follows: 0 - Fully active; 1 - Restricted in strenuous activity; 2 - Restricted in work activity, but ambulatory and capable of self-care; 3 - Capable of limited self-care; 4 - Completely disabled; 5 - Dead.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- ECOG Performance Status (PS)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 21
- group Id
- BG002
- value
- 19
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 75
- title
- Adenocarcinoma
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 9
- title
- Squamous
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 13
- title
- Not specified
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Histology
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 58
- title
- Yes
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 8
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 39
- title
- No
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Previous Radiotherapy
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- group Id
- BG001
- lower Limit
- 2
- upper Limit
- 3
- value
- 3
- group Id
- BG002
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- group Id
- BG003
- lower Limit
- 2
- upper Limit
- 7
- value
- 4
- group Id
- BG004
- lower Limit
- 1
- upper Limit
- 7
- value
- 3
- group Id
- BG005
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- dispersion Type
- INTER_QUARTILE_RANGE
- param Type
- MEDIAN
- title
- Previous lines of therapy
- unit Of Measure
- Lines of therapy
- population Description
- Participants receiving at least one dose of protocol therapy.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 26
- group Id
- BG001
- value
- 26
- group Id
- BG002
- value
- 26
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 97
- units
- Participants
- groups
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- BG000
- title
- NSCLC Arm A (Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- BG001
- title
- NSCLC Arm B (Tremelimumab, Durvalumab, LD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Durvalumab: Given IV Tremelimumab: Given IV
- id
- BG002
- title
- NSCLC Arm C (Tremelimumab, Durvalumab)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- BG003
- title
- CRC Arm A Tremelimumab, Durvalumab, HD-RT)
- description
- Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.. Durvalumab: Given IV Radiation Therapy: Undergo radiation therapy Tremelimumab: Given IV
- id
- BG004
- title
- CRC Arm B (Tremelimumab, Durvalumab, LD-RT)
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 46.0
- upper Limit
- 88.0
- value
- 65.5
- group Id
- BG001
- lower Limit
- 45.0
- upper Limit
- 77.0
- value
- 68.0
- group Id
- BG002
- lower Limit
- 29.0
- upper Limit
- 77.0
- value
- 65.5
- group Id
- BG003
- lower Limit
- 38
- upper Limit
- 79
- value
- 58
- group Id
- BG004
- lower Limit
- 29
- upper Limit
- 77
- value
- 59
- group Id
- BG005
- lower Limit
- 29.0
- upper Limit
- 88.0
- value
- 66.0
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 39
- title
- Female
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 58
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 6
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 25
- group Id
- BG002
- value
- 25
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 88
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- 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
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 4
- 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
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 8
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 22
- group Id
- BG002
- value
- 21
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 78
- 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
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 7
- 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
- 26
- group Id
- BG001
- value
- 26
- group Id
- BG002
- value
- 26
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 97
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 31
- title
- 0 (Fully active)
- measurements
- group Id
- BG000
- value
- 19
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 64
- title
- 1 (Restricted in strenuous activities)
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- title
- 2 (Restricted in work; capable of self care)
- description
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS) scale measures a patient's functional status in relation to cancer. The scale describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability. Scoring is as follows: 0 - Fully active; 1 - Restricted in strenuous activity; 2 - Restricted in work activity, but ambulatory and capable of self-care; 3 - Capable of limited self-care; 4 - Completely disabled; 5 - Dead.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- ECOG Performance Status (PS)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 21
- group Id
- BG002
- value
- 19
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 75
- title
- Adenocarcinoma
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 9
- title
- Squamous
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 13
- title
- Not specified
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Histology
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 16
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 58
- title
- Yes
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 8
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 39
- title
- No
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Previous Radiotherapy
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- group Id
- BG001
- lower Limit
- 2
- upper Limit
- 3
- value
- 3
- group Id
- BG002
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- group Id
- BG003
- lower Limit
- 2
- upper Limit
- 7
- value
- 4
- group Id
- BG004
- lower Limit
- 1
- upper Limit
- 7
- value
- 3
- group Id
- BG005
- lower Limit
- 2
- upper Limit
- 4
- value
- 3
- dispersion Type
- INTER_QUARTILE_RANGE
- param Type
- MEDIAN
- title
- Previous lines of therapy
- unit Of Measure
- Lines of therapy
- population Description
- Participants receiving at least one dose of protocol therapy.
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Preserved source evidence · Not medical advice
Triangle