TriangleNCT01245062 · OUTCOME
Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases
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
- Day 1 until death due to any cause (average of 20.3 months)
What was measured
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. NA indicates data was not available.
Analysis population: Primary Efficacy Population
Groups in this outcome
Trametinib
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
Chemotherapy
Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
| Group | Source count |
|---|---|
| Trametinib | 178 |
| Chemotherapy | 95 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | NA | Not reported | NA | NA | At the time of this report, there was limited follow-up for survival; therefore, the median and the confidence interval (CI) could not be estimated. |
| Chemotherapy | NA | Not reported | 6.8 | NA | At the time of this report, there was limited follow-up for survival; therefore, the median and the upper limit (UL) of the CI could not be estimated. |
Complete source fields
- classes
- categories
- measurements
- comment
- At the time of this report, there was limited follow-up for survival; therefore, the median and the confidence interval (CI) could not be estimated.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- At the time of this report, there was limited follow-up for survival; therefore, the median and the upper limit (UL) of the CI could not be estimated.
- group Id
- OG001
- lower Limit
- 6.8
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 178
- group Id
- OG001
- value
- 95
- units
- Participants
- description
- Overall survival was defined as the time from the date of randomization to the date of death due to any cause. NA indicates data was not available.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.
- id
- OG000
- title
- Trametinib
- description
- Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEDIAN
- population Description
- Primary Efficacy Population
- reporting Status
- POSTED
- time Frame
- Day 1 until death due to any cause (average of 20.3 months)
- title
- Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice