NCT03597295 · OUTCOME
Disease Control Rate (DCR)
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
- Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
What was measured
DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, at any post-baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Analysis population: Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
Groups in this outcome
Retifanlimab 500 mg
Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
| Group | Source count |
|---|---|
| Retifanlimab 500 mg | 94 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Retifanlimab 500 mg | 48.9 | Not reported | 38.5 | 59.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.5
- upper Limit
- 59.5
- value
- 48.9
- denoms
- counts
- group Id
- OG000
- value
- 94
- units
- Participants
- description
- DCR was defined as the percentage of participants with a confirmed overall response of CR, PR, or stable disease (SD), per RECIST v1.1, at any post-baseline visit until the first progressive disease (PD) or new anti-cancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
- id
- OG000
- title
- Retifanlimab 500 mg
- param Type
- NUMBER
- population Description
- Full Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
- title
- Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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