TriangleNCT01302834 · OUTCOME
Percentage of Participants Experiencing Early Death
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
What was measured
Early death is defined as death due to adverse event or within 30 days of treatment completion.
Analysis population: Eligible patients who started study treatment
Groups in this outcome
IMRT + Cisplatin
Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
IMRT + Cetuximab
Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
| Group | Source count |
|---|---|
| IMRT + Cisplatin | 398 |
| IMRT + Cetuximab | 394 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMRT + Cisplatin | 1.5 | Not reported | 0.6 | 3.3 | Not reported |
| IMRT + Cetuximab | 1.5 | Not reported | 0.6 | 3.3 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 1.0
- p Value Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 1.0
- p Value Comment
- Two-sided significance level = 0.05
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- upper Limit
- 3.3
- value
- 1.5
- group Id
- OG001
- lower Limit
- 0.6
- upper Limit
- 3.3
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 398
- group Id
- OG001
- value
- 394
- units
- Participants
- description
- Early death is defined as death due to adverse event or within 30 days of treatment completion.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cisplatin Cisplatin: 100 mg/m2 IV on days 1 and 22 of IMRT IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG000
- title
- IMRT + Cisplatin
- description
- Intensity-modulated radiotherapy (IMRT) with concurrent cetuximab Cetuximab: 400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks IMRT: 35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
- id
- OG001
- title
- IMRT + Cetuximab
- param Type
- NUMBER
- population Description
- Eligible patients who started study treatment
- reporting Status
- POSTED
- time Frame
- From randomization to last follow-up. Analysis was to occur after 180 deaths were reported. Analysis occurred after 133 deaths were reported. Maximum follow-up at time of analysis was 6.5 years.
- title
- Percentage of Participants Experiencing Early Death
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice