TriangleNCT01006980 · OUTCOME
Duration of Response
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 randomization (initiated in January 2010) until December 30, 2010.
What was measured
Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan-Meier method.
Analysis population: The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.
Groups in this outcome
Vemurafenib
Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
Dacarbazine
Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
| Group | Source count |
|---|---|
| Vemurafenib | 106 |
| Dacarbazine | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vemurafenib | 5.49 | Not reported | 3.98 | 5.72 | Not reported |
| Dacarbazine | NA | Not reported | 4.60 | NA | Median duration of response was not reached as only 2 of the 12 participants with a qualifying response had subsequent disease progression or death due to any cause at the time of the analysis. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.98
- upper Limit
- 5.72
- value
- 5.49
- comment
- Median duration of response was not reached as only 2 of the 12 participants with a qualifying response had subsequent disease progression or death due to any cause at the time of the analysis.
- group Id
- OG001
- lower Limit
- 4.60
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
- id
- OG000
- title
- Vemurafenib
- description
- Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
- id
- OG001
- title
- Dacarbazine
- param Type
- MEDIAN
- population Description
- The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.
- reporting Status
- POSTED
- time Frame
- From randomization (initiated in January 2010) until December 30, 2010.
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice