TriangleNCT02470897 · OUTCOME
Number of Participants Experiencing Genitourinary (GU) Acute Toxicity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- during treatment (days 1 to 5), 6 week follow up
What was measured
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for added grade 3 rectal toxicity with the use of a simultaneous integrated boost (SIB - Arm A). Acute toxicities were defined as occurring on-treatment or within 6 weeks.
Groups in this outcome
Grade 2 Toxicities: Arm A
Incidence of moderate GU toxicities on-treatment or within 6 weeks.
Grade 2 Toxicities: Arm B
Incidence of moderate GU toxicities on-treatment or within 6 weeks.
Grade 3 Toxicities: Arm A
Incidence of severe GU toxicities on-treatment or within 6 weeks.
Grade 3 Toxicities: Arm B
Incidence of severe GU toxicities on-treatment or within 6 weeks.
| Group | Source count |
|---|---|
| Grade 2 Toxicities: Arm A | 100 |
| Grade 2 Toxicities: Arm B | 15 |
| Grade 3 Toxicities: Arm A | 100 |
| Grade 3 Toxicities: Arm B | 15 |
Reported measurements
On Treatment (days 1 to 5 of SBRT delivery)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Grade 2 Toxicities: Arm A | 30 | Not reported | Not reported | Not reported | Not reported |
| Grade 2 Toxicities: Arm B | 3 | Not reported | Not reported | Not reported | Not reported |
| Grade 3 Toxicities: Arm A | 1 | Not reported | Not reported | Not reported | Not reported |
| Grade 3 Toxicities: Arm B | 0 | Not reported | Not reported | Not reported | Not reported |
6 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Grade 2 Toxicities: Arm A | 24 | Not reported | Not reported | Not reported | Not reported |
| Grade 2 Toxicities: Arm B | 5 | Not reported | Not reported | Not reported | Not reported |
| Grade 3 Toxicities: Arm A | 0 | Not reported | Not reported | Not reported | Not reported |
| Grade 3 Toxicities: Arm B | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- On Treatment (days 1 to 5 of SBRT delivery)
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- 6 weeks
- denoms
- counts
- group Id
- OG000
- value
- 100
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 100
- group Id
- OG003
- value
- 15
- units
- Participants
- description
- Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for added grade 3 rectal toxicity with the use of a simultaneous integrated boost (SIB - Arm A). Acute toxicities were defined as occurring on-treatment or within 6 weeks.
- groups
- description
- Incidence of moderate GU toxicities on-treatment or within 6 weeks.
- id
- OG000
- title
- Grade 2 Toxicities: Arm A
- description
- Incidence of moderate GU toxicities on-treatment or within 6 weeks.
- id
- OG001
- title
- Grade 2 Toxicities: Arm B
- description
- Incidence of severe GU toxicities on-treatment or within 6 weeks.
- id
- OG002
- title
- Grade 3 Toxicities: Arm A
- description
- Incidence of severe GU toxicities on-treatment or within 6 weeks.
- id
- OG003
- title
- Grade 3 Toxicities: Arm B
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- during treatment (days 1 to 5), 6 week follow up
- title
- Number of Participants Experiencing Genitourinary (GU) Acute Toxicity
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice