TriangleNCT00942331 · OUTCOME
Number of Patients Experiencing Grade 3+ 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
- Up to 7 years
What was measured
The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below.
Analysis population: Patients who started treatment are evaluable for adverse events.
Groups in this outcome
Arm II (GCB)
Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Arm I (GCP)
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm II (GCB) | 237 |
| Arm I (GCP) | 232 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm II (GCB) | 183 | Not reported | Not reported | Not reported | Not reported |
| Arm I (GCP) | 163 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 183
- group Id
- OG001
- value
- 163
- denoms
- counts
- group Id
- OG000
- value
- 237
- group Id
- OG001
- value
- 232
- units
- Participants
- description
- The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below.
- groups
- description
- Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm II (GCB)
- description
- Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm I (GCP)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Patients who started treatment are evaluable for adverse events.
- reporting Status
- POSTED
- time Frame
- Up to 7 years
- title
- Number of Patients Experiencing Grade 3+ Toxicity
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice