TriangleNCT02302807 · OUTCOME
Percentage of Participants With Adverse Events (AEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 46 months after first participant enrolled
What was measured
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Analysis population: Safety analyses was performed on all randomized patients who received any amount of study treatment, with patients grouped according to whether any amount of atezolizumab was received including the case when atezolizumab was received in error.
Groups in this outcome
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Atezolizumab
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
IC2/3 Chemotherapy
PD-L1 immunohistochemistry (IHC) score of IC2/3
IC2/3 Atezolizumab
PD-L1 immunohistochemistry (IHC) score of IC2/3
IC1/2/3 Chemotherapy
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
IC1/2/3 Atezolizumab
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
| Group | Source count |
|---|---|
| Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 443 |
| Atezolizumab | 459 |
| IC2/3 Chemotherapy | 112 |
| IC2/3 Atezolizumab | 114 |
| IC1/2/3 Chemotherapy | 297 |
| IC1/2/3 Atezolizumab | 312 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel) | 98.2 | Not reported | Not reported | Not reported | Not reported |
| Atezolizumab | 95.0 | Not reported | Not reported | Not reported | Not reported |
| IC2/3 Chemotherapy | 98.2 | Not reported | Not reported | Not reported | Not reported |
| IC2/3 Atezolizumab | 96.5 | Not reported | Not reported | Not reported | Not reported |
| IC1/2/3 Chemotherapy | 98.7 | Not reported | Not reported | Not reported | Not reported |
| IC1/2/3 Atezolizumab | 96.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 98.2
- group Id
- OG001
- value
- 95.0
- group Id
- OG002
- value
- 98.2
- group Id
- OG003
- value
- 96.5
- group Id
- OG004
- value
- 98.7
- group Id
- OG005
- value
- 96.2
- denoms
- counts
- group Id
- OG000
- value
- 443
- group Id
- OG001
- value
- 459
- group Id
- OG002
- value
- 112
- group Id
- OG003
- value
- 114
- group Id
- OG004
- value
- 297
- group Id
- OG005
- value
- 312
- units
- Participants
- description
- An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
- groups
- description
- Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
- id
- OG000
- title
- Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
- description
- Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
- id
- OG001
- title
- Atezolizumab
- description
- PD-L1 immunohistochemistry (IHC) score of IC2/3
- id
- OG002
- title
- IC2/3 Chemotherapy
- description
- PD-L1 immunohistochemistry (IHC) score of IC2/3
- id
- OG003
- title
- IC2/3 Atezolizumab
- description
- PD-L1 immunohistochemistry (IHC) score of IC1/2/3
- id
- OG004
- title
- IC1/2/3 Chemotherapy
- description
- PD-L1 immunohistochemistry (IHC) score of IC1/2/3
- id
- OG005
- title
- IC1/2/3 Atezolizumab
- param Type
- NUMBER
- population Description
- Safety analyses was performed on all randomized patients who received any amount of study treatment, with patients grouped according to whether any amount of atezolizumab was received including the case when atezolizumab was received in error.
- reporting Status
- POSTED
- time Frame
- Up to approximately 46 months after first participant enrolled
- title
- Percentage of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- percentage
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice