Comparison · NCT02106494-sae
APF530 + Fosaprepitant + Dexamethasone vs Ondansetron + Fosaprepitant + Dexamethasone: 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. APF530 + Fosaprepitant + Dexamethasone vs Ondansetron + Fosaprepitant + Dexamethasone: serious adverse events. Trial comparisons, record NCT02106494-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02106494-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 | 0.0921 | 0.0689 | 0.122 | wilson | |
| Risk in group 2 | 0.061 | 0.0425 | 0.0868 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0311 | -0.00358 | 0.0664 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.51 | 0.953 | 2.39 | log | |
| Odds ratio, group 1 over group 2 | 1.56 | 0.95 | 2.57 | log | |
| Number needed to harm, for one more participant with a serious adverse event on APF530 + Fosaprepitant + Dexamethasone than on Ondansetron + Fosaprepitant + Dexamethasone | 32.2 | 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 | APF530 + Fosaprepitant + Dexamethasone | Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID | 42 | 456 | EG000 |
| Group 2 | Ondansetron + Fosaprepitant + Dexamethasone | Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID | 28 | 459 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The reporting period for AEs was the period starting from the time of informed consent signature until 30±3 days after study drug administration (Day 1 of chemotherapy cycle). Treatment-emergent AEs were those that either began or increased in severity after administration of study drug and within 8 days of study drug administration.
Source ClinicalTrials.gov
Trial
- Title
- A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
- NCT number
- NCT02106494
- Phases
- PHASE3
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Interventions
- APF530, Ondansetron, Ondansetron placebo, APF530 placebo, Fosaprepitant, Dexamethasone
- Lead sponsor
- Heron Therapeutics
- Results first posted
- 2016-12-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02106494?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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