Comparison · NCT05098067-sae
Intervention Group vs Placebo Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Intervention Group vs Placebo Group: serious adverse events. Trial comparisons, record NCT05098067-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05098067-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 | 0 | 0.204 | wilson | |
| Risk in group 2 | 0 | 0 | 0.204 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.204 | 0.204 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intervention Group | Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.~Capsaicin Topical Cream: 5g 0.075% applied once~Metoclopramide: 10mg IV once~Ondansetron: 8mg IV once if needed~Lactated Ringers, Intravenous: 1000cc once | 0 | 15 | EG000 |
| Group 2 | Placebo Group | Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.~Metoclopramide: 10mg IV once~Ondansetron: 8mg IV once if needed~Lactated Ringers, Intravenous: 1000cc once | 0 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Data collected over length of emergency room visit an average of 1.5 hours per participant
Source ClinicalTrials.gov
Trial
- Title
- Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy
- NCT number
- NCT05098067
- Phases
- PHASE2
- Conditions
- Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy
- Interventions
- Capsaicin Topical Cream, Metoclopramide, Ondansetron, Lactated Ringers, Intravenous
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Results first posted
- 2024-02-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05098067?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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GET https://conductscience.org/api/comparisons/v1/NCT05098067-sae