TriangleNCT00154102 · OUTCOME
Duration of Response - Independent Review Committee (IRC) Assessments
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
- Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
What was measured
Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment). Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Analysis population: ITT population (allocation to treatment groups as randomized and treated)
Groups in this outcome
Cetuximab Plus FOLFIRI
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
FOLFIRI Alone
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
| Group | Source count |
|---|---|
| Cetuximab Plus FOLFIRI | 599 |
| FOLFIRI Alone | 599 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab Plus FOLFIRI | 9.6 | Not reported | 9.1 | 12.9 | Not reported |
| FOLFIRI Alone | 7.7 | Not reported | 6.7 | 8.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.1
- upper Limit
- 12.9
- value
- 9.6
- group Id
- OG001
- lower Limit
- 6.7
- upper Limit
- 8.3
- value
- 7.7
- denoms
- counts
- group Id
- OG000
- value
- 599
- group Id
- OG001
- value
- 599
- units
- Participants
- description
- Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment). Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
- id
- OG000
- title
- Cetuximab Plus FOLFIRI
- description
- Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
- id
- OG001
- title
- FOLFIRI Alone
- param Type
- MEDIAN
- population Description
- ITT population (allocation to treatment groups as randomized and treated)
- reporting Status
- POSTED
- time Frame
- Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
- title
- Duration of Response - Independent Review Committee (IRC) Assessments
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice