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-High 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-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High 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 OR ≥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 | 205 |
| Monotherapy | 209 |
| Standard of Care | 207 |
Reported measurements
NFBLSI - 18 Score (Average overall visits)
| Group | Source count |
|---|---|
| Combination Therapy | 129 |
| Monotherapy | 131 |
| Standard of Care | 119 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | -3.9 | 0.85 | Not reported | Not reported | Not reported |
| Monotherapy | -2.0 | 0.87 | Not reported | Not reported | Not reported |
| Standard of Care | -5.7 | 0.95 | Not reported | Not reported | Not reported |
FACT-BL TOI (Average overall visits)
| Group | Source count |
|---|---|
| Combination Therapy | 129 |
| Monotherapy | 131 |
| Standard of Care | 119 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | -5.8 | 1.09 | Not reported | Not reported | Not reported |
| Monotherapy | -2.6 | 1.11 | Not reported | Not reported | Not reported |
| Standard of Care | -8.0 | 1.22 | Not reported | Not reported | Not reported |
FACT-BL Total score (Average overall visits)
| Group | Source count |
|---|---|
| Combination Therapy | 129 |
| Monotherapy | 131 |
| Standard of Care | 119 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | -8.0 | 1.47 | Not reported | Not reported | Not reported |
| Monotherapy | -2.7 | 1.51 | Not reported | Not reported | Not reported |
| Standard of Care | -10.1 | 1.65 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.36
- group Description
- NFBLSI- 18 score (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1373
- 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
- 1.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.27
- group Description
- NFBLSI- 18 score (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0034
- 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
- 3.8
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -1.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.39
- group Description
- FACT-BL TOI (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1774
- 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
- 2.2
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 2.19
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.65
- group Description
- FACT-BL TOI (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0011
- 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
- 5.4
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -2.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.38
- group Description
- FACT-BL Total score (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3494
- 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
- 2.1
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 2.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.71
- group Description
- FACT-BL Total score (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0011
- 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
- 7.3
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -0.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.36
- group Description
- NFBLSI- 18 score (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1373
- 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
- 1.26
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.27
- group Description
- NFBLSI- 18 score (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0034
- 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
- 3.8
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -1.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.39
- group Description
- FACT-BL TOI (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1774
- 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
- 2.2
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 2.19
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.65
- group Description
- FACT-BL TOI (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0011
- 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
- 5.4
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -2.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.38
- group Description
- FACT-BL Total score (Average overall visits)
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3494
- 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
- 2.1
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 2.96
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.71
- group Description
- FACT-BL Total score (Average overall visits)
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0011
- 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
- 7.3
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.85
- value
- -3.9
- group Id
- OG001
- spread
- 0.87
- value
- -2.0
- group Id
- OG002
- spread
- 0.95
- value
- -5.7
- denoms
- counts
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 131
- group Id
- OG002
- value
- 119
- units
- Participants
- title
- NFBLSI - 18 Score (Average overall visits)
- categories
- measurements
- group Id
- OG000
- spread
- 1.09
- value
- -5.8
- group Id
- OG001
- spread
- 1.11
- value
- -2.6
- group Id
- OG002
- spread
- 1.22
- value
- -8.0
- denoms
- counts
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 131
- group Id
- OG002
- value
- 119
- units
- Participants
- title
- FACT-BL TOI (Average overall visits)
- categories
- measurements
- group Id
- OG000
- spread
- 1.47
- value
- -8.0
- group Id
- OG001
- spread
- 1.51
- value
- -2.7
- group Id
- OG002
- spread
- 1.65
- value
- -10.1
- denoms
- counts
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 131
- group Id
- OG002
- value
- 119
- units
- Participants
- title
- FACT-BL Total score (Average overall visits)
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 209
- group Id
- OG002
- value
- 207
- 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-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High 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 OR ≥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-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
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Preserved source evidence · Not medical advice