NCT00433550 · 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
- Up to 2 years
What was measured
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.
Analysis population: All patients who achieved a CR or PR are included in this analysis.
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) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 9.0 | Not reported | 7.8 | NA | Too few events have occurred to estimate the upper 95% Confidence Interval. |
Complete source fields
- classes
- categories
- measurements
- comment
- Too few events have occurred to estimate the upper 95% Confidence Interval.
- group Id
- OG000
- lower Limit
- 7.8
- upper Limit
- NA
- value
- 9.0
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.
- 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
- All patients who achieved a CR or PR are included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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