NCT03762018 · OUTCOME
Adverse Events
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
- From randomization to 90 days after the last dose of protocol treatment, up to 52 months.
What was measured
Adverse events, according to CTCAE v5.0.
Analysis population: Safety population, patients who received at least 1 dose of treatment: 198 in ABC/200 in BC. But, one patient assigned in the BC arm received ABC. For the safety analysis, the patient is evaluated according to the treatment received irrespective of the allocated treatment at randomization (safety population: 199 in each arm). Of note, in the next section, all-cause mortality was assessed for all randomized, while serious adverse events/adverse events were assessed for the safety population.
Groups in this outcome
Atezolizumab Plus Bevacizumab Plus Chemotherapy
Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Bevacizumab Plus Chemotherapy
Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
| Group | Source count |
|---|---|
| Atezolizumab Plus Bevacizumab Plus Chemotherapy | 199 |
| Bevacizumab Plus Chemotherapy | 199 |
Reported measurements
Experienced AE/SAE
Experienced AE/SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab Plus Bevacizumab Plus Chemotherapy | 197 | Not reported | Not reported | Not reported | Not reported |
| Bevacizumab Plus Chemotherapy | 197 | Not reported | Not reported | Not reported | Not reported |
Experienced SAE
Experienced AE/SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab Plus Bevacizumab Plus Chemotherapy | 92 | Not reported | Not reported | Not reported | Not reported |
| Bevacizumab Plus Chemotherapy | 67 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 197
- title
- Experienced AE/SAE
- title
- Experienced AE/SAE
- categories
- measurements
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 67
- title
- Experienced AE/SAE
- title
- Experienced SAE
- denoms
- counts
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 199
- units
- Participants
- description
- Adverse events, according to CTCAE v5.0.
- groups
- description
- Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
- id
- OG000
- title
- Atezolizumab Plus Bevacizumab Plus Chemotherapy
- description
- Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
- id
- OG001
- title
- Bevacizumab Plus Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population, patients who received at least 1 dose of treatment: 198 in ABC/200 in BC. But, one patient assigned in the BC arm received ABC. For the safety analysis, the patient is evaluated according to the treatment received irrespective of the allocated treatment at randomization (safety population: 199 in each arm). Of note, in the next section, all-cause mortality was assessed for all randomized, while serious adverse events/adverse events were assessed for the safety population.
- reporting Status
- POSTED
- time Frame
- From randomization to 90 days after the last dose of protocol treatment, up to 52 months.
- title
- Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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