TriangleNCT00265941 · OUTCOME
Rate of Mucositis Toxicity ≥ Grade 3
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 treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
What was measured
Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Analysis population: Randomized eligible patients with follow-up data
Groups in this outcome
RT + Cisplatin
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
RT + Cisplatin + Cetuximab
Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
| Group | Source count |
|---|---|
| RT + Cisplatin | 447 |
| RT + Cisplatin + Cetuximab | 444 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RT + Cisplatin | 33.3 | Not reported | 29.0 | 37.7 | Not reported |
| RT + Cisplatin + Cetuximab | 43.2 | Not reported | 38.6 | 47.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.0
- upper Limit
- 37.7
- value
- 33.3
- group Id
- OG001
- lower Limit
- 38.6
- upper Limit
- 47.9
- value
- 43.2
- denoms
- counts
- group Id
- OG000
- value
- 447
- group Id
- OG001
- value
- 444
- units
- Participants
- description
- Grade 3 or higher Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation mucositis definitely, probably, or possibly related to protocol treatment. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin
- id
- OG000
- title
- RT + Cisplatin
- description
- Radiation therapy (RT) as accelerated fractionation by concomitant boost (AFX-CB) or intensity-modulated radiation therapy (IMRT) plus cisplatin plus cetuximab
- id
- OG001
- title
- RT + Cisplatin + Cetuximab
- param Type
- NUMBER
- population Description
- Randomized eligible patients with follow-up data
- reporting Status
- POSTED
- time Frame
- From start of treatment until 434 failures have occurred, approximately 5 years from start of study. (Patients are followed until death or study termination, whichever occurs first.)
- title
- Rate of Mucositis Toxicity ≥ Grade 3
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice