TriangleNCT00433550 · OUTCOME
Overall Survival
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
- Up to 2 years
What was measured
Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.
Analysis population: One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
Groups in this outcome
All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
Group 1 (6/6 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15\> \> Group 2 (6/7 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.\> \> Group 3 (7/7 UGT1A1 genotype):\> Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
| Group | Source count |
|---|---|
| All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 13.4 | Not reported | 10.5 | 18.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.5
- upper Limit
- 18.1
- value
- 13.4
- denoms
- counts
- group Id
- OG000
- value
- 32
- units
- Participants
- description
- Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Group 1 (6/6 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15\> \> Group 2 (6/7 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.\> \> Group 3 (7/7 UGT1A1 genotype):\> Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
- id
- OG000
- title
- All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
- param Type
- MEDIAN
- population Description
- One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice