TriangleNCT00009737 · OUTCOME
Number of Participants With Any Adverse Events and Serious Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to Week 29
What was measured
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Analysis population: The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment
Groups in this outcome
Capecitabine
Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
5-Fluorouracil + Leucovorin
Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
| Group | Source count |
|---|---|
| Capecitabine | 995 |
| 5-Fluorouracil + Leucovorin | 974 |
Reported measurements
All adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Capecitabine | 910 | Not reported | Not reported | Not reported | Not reported |
| 5-Fluorouracil + Leucovorin | 885 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Capecitabine | 181 | Not reported | Not reported | Not reported | Not reported |
| 5-Fluorouracil + Leucovorin | 182 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 910
- group Id
- OG001
- value
- 885
- title
- All adverse events
- categories
- measurements
- group Id
- OG000
- value
- 181
- group Id
- OG001
- value
- 182
- title
- Serious adverse events
- denoms
- counts
- group Id
- OG000
- value
- 995
- group Id
- OG001
- value
- 974
- units
- Participants
- description
- An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
- groups
- description
- Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
- id
- OG000
- title
- Capecitabine
- description
- Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
- id
- OG001
- title
- 5-Fluorouracil + Leucovorin
- param Type
- NUMBER
- population Description
- The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment
- reporting Status
- POSTED
- time Frame
- Up to Week 29
- title
- Number of Participants With Any Adverse Events and Serious Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice