Comparison · NCT02407990-sae
BGB-A317 Phase 1A vs BGB-A317 Phase 1B: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. BGB-A317 Phase 1A vs BGB-A317 Phase 1B: serious adverse events. Trial comparisons, record NCT02407990-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02407990-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.345 | 0.265 | 0.435 | wilson | |
| Risk in group 2 | 0.391 | 0.34 | 0.444 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0462 | -0.143 | 0.0573 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.882 | 0.664 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.82 | 0.527 | 1.27 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on BGB-A317 Phase 1A than on BGB-A317 Phase 1B | 21.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | BGB-A317 Phase 1A | In Part 1, participants were dosed at 0.5 mg/kg, 2 mg/kg, 5 mg/kg, and 10 mg/kg Q2W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days in duration. In Part 2, participants received selected dosing based on Part 1 at Q2W and/or Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent. Each treatment cycle was 28 days and 21 days in duration, respectively. In Part 3: participants received a fixed dose that did not exceed the selected MTD, which is 200 mg Q3W until death, disease progression, unacceptable toxicities, or withdrawal of consent.. Each treatment cycle was 21 days in duration. | 40 | 116 | EG000 |
| Group 2 | BGB-A317 Phase 1B | Participants were dosed at 5 mg/kg Q3W until confirmed disease progression, intolerable toxicity, participant discontinuation/ withdrawal or at the discretion of the Investigator in consultation with Sponsor, as determined by the safety monitoring committee, in 9 indication expansion Arms. Each treatment cycle was 21 days in duration. | 131 | 335 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day -28 through 5 years and 2 months
Source ClinicalTrials.gov
Trial
- Title
- Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Participants With Advanced Tumors
- NCT number
- NCT02407990
- Phases
- PHASE1
- Conditions
- Advanced Cancer
- Interventions
- BGB-A317, BGB-A317
- Lead sponsor
- BeiGene
- Results first posted
- 2021-11-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02407990?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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