NCT04145700 · OUTCOME
Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Months
- Interval / dispersion
- Not reported
- Time frame
- Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 Months)
What was measured
DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence.
Analysis population: All randomized participants who had CR or PR responses. For Gemcitabine + Docetaxel, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed.
Groups in this outcome
Ramucirumab + Gemcitabine + Docetaxel
Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
Gemcitabine + Docetaxel
Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
| Group | Source count |
|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 1 |
| Gemcitabine + Docetaxel | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | NA | Not reported | Not reported | Not reported | DoR couldn't be calculated as the participant did not achieve the event and was censored. |
Complete source fields
- classes
- categories
- measurements
- comment
- DoR couldn't be calculated as the participant did not achieve the event and was censored.
- group Id
- OG000
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence.
- groups
- description
- Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
- id
- OG000
- title
- Ramucirumab + Gemcitabine + Docetaxel
- description
- Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
- id
- OG001
- title
- Gemcitabine + Docetaxel
- param Type
- NUMBER
- population Description
- All randomized participants who had CR or PR responses. For Gemcitabine + Docetaxel, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed.
- reporting Status
- POSTED
- time Frame
- Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 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
Triangle