TriangleNCT02516241 · OUTCOME
Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).
What was measured
Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | 15.2 | Not reported | 9.6 | 21.8 | Not reported |
| Monotherapy | 9.7 | Not reported | 5.4 | 15.7 | Not reported |
| Standard of Care | 15.6 | Not reported | 9.6 | 22.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.6
- upper Limit
- 21.8
- value
- 15.2
- group Id
- OG001
- lower Limit
- 5.4
- upper Limit
- 15.7
- value
- 9.7
- group Id
- OG002
- lower Limit
- 9.6
- upper Limit
- 22.9
- value
- 15.6
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 137
- units
- Participants
- description
- Alive and progression-free at 12 months (APF12) was defined as the Kaplan-Meier estimate of PFS (per RECIST 1.1 as assessed by investigator) at 12 months.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- 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
- Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to 12 months or the data cut-off date (27JAN2020).
- title
- Alive and Progression-free at 12 Months (APF12), PD-L1-Low/Negative Analysis Set
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice