NCT03215706 · 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
- From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
What was measured
DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.
Analysis population: All confirmed Responders, Global Population
Groups in this outcome
Treatment A
Nivolumab + Ipilimumab + Chemotherapy
Treatment B
Chemotherapy only
| Group | Source count |
|---|---|
| Treatment A | 137 |
| Treatment B | 90 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A | 13.01 | Not reported | 8.71 | 20.21 | Not reported |
| Treatment B | 5.59 | Not reported | 4.37 | 7.10 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.71
- upper Limit
- 20.21
- value
- 13.01
- group Id
- OG001
- lower Limit
- 4.37
- upper Limit
- 7.10
- value
- 5.59
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 90
- units
- Participants
- description
- DoR was defined as the time between the date of first confirmed documented response (CR or PR) to the date of the first documented BICR-assessed tumor progression (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who started subsequent therapy (including palliative local therapy) without a prior reported progression were censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy (including palliative local therapy). Participants who died without a reported prior progression were considered to have progressed on the date of their death. For subjects who neither progressed nor died, DoR was censored on the date of their last evaluable tumor assessment. DoR was evaluated for responders (confirmed CR or PR) only.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab + Ipilimumab + Chemotherapy
- id
- OG000
- title
- Treatment A
- description
- Chemotherapy only
- id
- OG001
- title
- Treatment B
- param Type
- MEDIAN
- population Description
- All confirmed Responders, Global Population
- reporting Status
- POSTED
- time Frame
- From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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