Comparison · NCT03383692-sae
Cohort 1: DS-8201a + Ritonavir vs Cohort 2: DS-8201a + Itraconazole: 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. Cohort 1: DS-8201a + Ritonavir vs Cohort 2: DS-8201a + Itraconazole: serious adverse events. Trial comparisons, record NCT03383692-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03383692-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 | 0.118 | 0.0329 | 0.343 | wilson | |
| Risk in group 2 | 0.13 | 0.0454 | 0.321 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0128 | -0.222 | 0.228 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.902 | 0.169 | 4.82 | log | |
| Odds ratio, group 1 over group 2 | 0.889 | 0.132 | 6 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort 1: DS-8201a + Ritonavir than on Cohort 2: DS-8201a + Itraconazole | 78.2 | 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 | Cohort 1: DS-8201a + Ritonavir | Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg ritonavir twice daily on Day 17 of Cycle 2 until Day 21 of Cycle 3. | 2 | 17 | EG000 |
| Group 2 | Cohort 2: DS-8201a + Itraconazole | Participants who received 5.4 mg/kg DS-8201a as an intravenous infusion once every 3 weeks and 200 mg itraconazole BID on Day 17 of Cycle 2 followed by 200 mg QD until Day 21 of Cycle 3. | 3 | 23 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected from baseline up to approximately 9 months post-dose.
Source ClinicalTrials.gov
Trial
- Title
- Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
- NCT number
- NCT03383692
- Phases
- PHASE1
- Conditions
- Neoplasm Metastasis
- Interventions
- DS-8201a, Ritonavir, Itraconazole
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Results first posted
- 2021-06-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03383692?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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