TriangleNCT00033631 · OUTCOME
Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity
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
- Not reported
- Time frame
- From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint
What was measured
Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
Analysis population: Eligible patients with acute adverse event data who did not withdraw consent.
Groups in this outcome
70.2 Gy
70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
79.2 Gy
79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
| Group | Source count |
|---|---|
| 70.2 Gy | 733 |
| 79.2 Gy | 728 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 70.2 Gy | 18.8 | Not reported | Not reported | Not reported | Not reported |
| 79.2 Gy | 21.0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.29
- p Value Comment
- Two-sided significance level = 0.05
- statistical Method
- Chi-squared
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.29
- p Value Comment
- Two-sided significance level = 0.05
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- value
- 18.8
- group Id
- OG001
- value
- 21.0
- denoms
- counts
- group Id
- OG000
- value
- 733
- group Id
- OG001
- value
- 728
- units
- Participants
- description
- Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
- groups
- description
- 70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
- id
- OG000
- title
- 70.2 Gy
- description
- 79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
- id
- OG001
- title
- 79.2 Gy
- param Type
- NUMBER
- population Description
- Eligible patients with acute adverse event data who did not withdraw consent.
- reporting Status
- POSTED
- time Frame
- From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint
- title
- Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice