TriangleNCT02516241 · OUTCOME
Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Error
- Time frame
- At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
What was measured
the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse
Analysis population: The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
Groups in this outcome
Combination Therapy
MEDI4736 (Durvalumab) + Tremelimumab
Monotherapy
MEDI4736 (Durvalumab)
Standard of Care
Standard of Care Chemotherapy Treatment
| Group | Source count |
|---|---|
| Combination Therapy | 137 |
| Monotherapy | 137 |
| Standard of Care | 137 |
Reported measurements
NFBLSI - 18 Score (Average overall visits)
| Group | Source count |
|---|---|
| Combination Therapy | 91 |
| Monotherapy | 73 |
| Standard of Care | 69 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | -3.4 | 1.01 | Not reported | Not reported | Not reported |
| Monotherapy | -3.8 | 1.18 | Not reported | Not reported | Not reported |
| Standard of Care | -2.0 | 1.16 | Not reported | Not reported | Not reported |
FACT-BL TOI (Average overall visits)
| Group | Source count |
|---|---|
| Combination Therapy | 91 |
| Monotherapy | 73 |
| Standard of Care | 69 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | -4.9 | 1.18 | Not reported | Not reported | Not reported |
| Monotherapy | -5.0 | 1.39 | Not reported | Not reported | Not reported |
| Standard of Care | -3.0 | 1.36 | Not reported | Not reported | Not reported |
FACT-BL Total score (Average overall visits)
| Group | Source count |
|---|---|
| Combination Therapy | 91 |
| Monotherapy | 73 |
| Standard of Care | 69 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | -5.7 | 1.62 | Not reported | Not reported | Not reported |
| Monotherapy | -6.5 | 1.90 | Not reported | Not reported | Not reported |
| Standard of Care | -3.2 | 1.86 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -4.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.69
- group Description
- NFBLSI- 18 score (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3865
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -1.3
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -5.05
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.49
- group Description
- NFBLSI- 18 score (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2840
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -1.8
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -5.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.66
- group Description
- FACT-BL TOI (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2970
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -1.9
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -5.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.83
- group Description
- FACT-BL TOI (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3026
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -2.0
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -7.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.38
- group Description
- FACT-BL Total score (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3168
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -2.5
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -8.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.96
- group Description
- FACT-BL Total score (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2179
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -3.3
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -4.35
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.69
- group Description
- NFBLSI- 18 score (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3865
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -1.3
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -5.05
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.49
- group Description
- NFBLSI- 18 score (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2840
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -1.8
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -5.41
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.66
- group Description
- FACT-BL TOI (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2970
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -1.9
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -5.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.83
- group Description
- FACT-BL TOI (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3026
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -2.0
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -7.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.38
- group Description
- FACT-BL Total score (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3168
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -2.5
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -8.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.96
- group Description
- FACT-BL Total score (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2179
- p Value Comment
- MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
- param Type
- Mean Difference (Final Values)
- param Value
- -3.3
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.01
- value
- -3.4
- group Id
- OG001
- spread
- 1.18
- value
- -3.8
- group Id
- OG002
- spread
- 1.16
- value
- -2.0
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 73
- group Id
- OG002
- value
- 69
- units
- Participants
- title
- NFBLSI - 18 Score (Average overall visits)
- categories
- measurements
- group Id
- OG000
- spread
- 1.18
- value
- -4.9
- group Id
- OG001
- spread
- 1.39
- value
- -5.0
- group Id
- OG002
- spread
- 1.36
- value
- -3.0
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 73
- group Id
- OG002
- value
- 69
- units
- Participants
- title
- FACT-BL TOI (Average overall visits)
- categories
- measurements
- group Id
- OG000
- spread
- 1.62
- value
- -5.7
- group Id
- OG001
- spread
- 1.90
- value
- -6.5
- group Id
- OG002
- spread
- 1.86
- value
- -3.2
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 73
- group Id
- OG002
- value
- 69
- units
- Participants
- title
- FACT-BL Total score (Average overall visits)
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 137
- units
- Participants
- description
- the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse
- dispersion Type
- Standard Error
- groups
- description
- MEDI4736 (Durvalumab) + Tremelimumab
- id
- OG000
- title
- Combination Therapy
- description
- MEDI4736 (Durvalumab)
- id
- OG001
- title
- Monotherapy
- description
- Standard of Care Chemotherapy Treatment
- id
- OG002
- title
- Standard of Care
- param Type
- MEAN
- population Description
- The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
- reporting Status
- POSTED
- time Frame
- At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
- title
- Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice