TriangleNCT00956007 · OUTCOME
Percentage of Participants With Other ≥ Grade 3 Adverse Events Related to Protocol Treatment
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 start of radiation therapy to 90 days.
What was measured
Adverse events other than dysphagia, dermatitis radiation, and rash acneiform. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.
Analysis population: Randomized eligible participants who started protocol treatment
Groups in this outcome
IMRT
Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
IMRT Plus Cetuximab
Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
| Group | Source count |
|---|---|
| IMRT | 282 |
| IMRT Plus Cetuximab | 276 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| IMRT | 33.0 | Not reported | 27.8 | 38.7 | Not reported |
| IMRT Plus Cetuximab | 64.1 | Not reported | 58.3 | 69.6 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.8
- upper Limit
- 38.7
- value
- 33.0
- group Id
- OG001
- lower Limit
- 58.3
- upper Limit
- 69.6
- value
- 64.1
- denoms
- counts
- group Id
- OG000
- value
- 282
- group Id
- OG001
- value
- 276
- units
- Participants
- description
- Adverse events other than dysphagia, dermatitis radiation, and rash acneiform. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Adverse events (AEs) assessed to be definitely, probably, or possibly related to protocol treatment were included. If relationship was missing, it was assumed to be definitely, probably, or possibly related to protocol treatment. Acute adverse events are those occurring within 90 days of the start of radiation therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Radiation therapy: 60 Gy intensity-modulated radiotherapy (IMRT), 2 Gy/day in 30 fractions (5 days a week for 6 weeks).
- id
- OG000
- title
- IMRT
- description
- Radiation therapy (RT): 60 Gy IMRT, 2 Gy/day in 30 fractions (5 days a week for 6 weeks). Cetuximab: 400 mg/m\^2 intravenously (IV) at least 5 days prior to IMRT; 250 mg/m\^2 IV once a week for 6 weeks during RT and continuing 4 weeks after RT.
- id
- OG001
- title
- IMRT Plus Cetuximab
- param Type
- NUMBER
- population Description
- Randomized eligible participants who started protocol treatment
- reporting Status
- POSTED
- time Frame
- From start of radiation therapy to 90 days.
- title
- Percentage of Participants With Other ≥ Grade 3 Adverse Events Related to Protocol Treatment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice