TriangleNCT02516241 · OUTCOME
Duration of Response (DoR), 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
What was measured
Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1).
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 | 12.9 | Not reported | 5.5 | NA | upper limit is not reached. |
| Monotherapy | 5.6 | Not reported | 3.8 | NA | upper limit is not reached. |
| Standard of Care | 5.7 | Not reported | 3.9 | 8.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- upper limit is not reached.
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- NA
- value
- 12.9
- comment
- upper limit is not reached.
- group Id
- OG001
- lower Limit
- 3.8
- upper Limit
- NA
- value
- 5.6
- group Id
- OG002
- lower Limit
- 3.9
- upper Limit
- 8.2
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 137
- units
- Participants
- description
- Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1).
- dispersion Type
- Inter-Quartile Range
- 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
- MEDIAN
- 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 the data cut-off date (27JAN2020, a maximum of 5 years).
- title
- Duration of Response (DoR), PD-L1-Low/Negative Analysis Set
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice