TriangleNCT03875235 · OUTCOME
Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.
What was measured
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Analysis population: Full analysis set - subjects with objective response and measurable disease at baseline
Groups in this outcome
Durvalumab + Gemcitabine + Cisplatin
Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin
Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
| Group | Source count |
|---|---|
| Durvalumab + Gemcitabine + Cisplatin | 91 |
| Placebo + Gemcitabine + Cisplatin | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Durvalumab + Gemcitabine + Cisplatin | 6.4 | Not reported | 5.9 | 8.1 | Not reported |
| Placebo + Gemcitabine + Cisplatin | 6.2 | Not reported | 4.4 | 7.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.9
- upper Limit
- 8.1
- value
- 6.4
- group Id
- OG001
- lower Limit
- 4.4
- upper Limit
- 7.3
- value
- 6.2
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 64
- units
- Participants
- description
- The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- id
- OG000
- title
- Durvalumab + Gemcitabine + Cisplatin
- description
- Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- id
- OG001
- title
- Placebo + Gemcitabine + Cisplatin
- param Type
- MEDIAN
- population Description
- Full analysis set - subjects with objective response and measurable disease at baseline
- reporting Status
- POSTED
- time Frame
- Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice