TriangleNCT02108652 · OUTCOME
Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)
What was measured
DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.
Analysis population: Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.
Groups in this outcome
Cohort 2: Participants With Second-line or Beyond Treatments
Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
| Group | Source count |
|---|---|
| Cohort 2: Participants With Second-line or Beyond Treatments | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: Participants With Second-line or Beyond Treatments | NA | Not reported | 2.1 | NA | The median DOR and upper limit for the Full Range were not reached at a median follow up of 21.060 months on study. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median DOR and upper limit for the Full Range were not reached at a median follow up of 21.060 months on study.
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 49
- units
- Participants
- description
- DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.
- dispersion Type
- Full Range
- groups
- description
- Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
- id
- OG000
- title
- Cohort 2: Participants With Second-line or Beyond Treatments
- param Type
- MEDIAN
- population Description
- Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.
- reporting Status
- POSTED
- time Frame
- Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)
- title
- Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice