TriangleNCT03710876 · OUTCOME
Adverse Events Grade 3 or 4.
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
- 4 years and 8 months.
What was measured
To evaluate the number of patients with Common Terminology Criteria for Adverse Events Grade 3 or 4.
Analysis population: Safety Analysis Set
Groups in this outcome
Treatment Group
rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
Control Group
Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
| Group | Source count |
|---|---|
| Treatment Group | 27 |
| Control Group | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Group | 18 | Not reported | Not reported | Not reported | Not reported |
| Control Group | 17 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 17
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- To evaluate the number of patients with Common Terminology Criteria for Adverse Events Grade 3 or 4.
- groups
- description
- rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
- id
- OG000
- title
- Treatment Group
- description
- Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
- id
- OG001
- title
- Control Group
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set
- reporting Status
- POSTED
- time Frame
- 4 years and 8 months.
- title
- Adverse Events Grade 3 or 4.
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice