Comparison · NCT02075047-sae
Ziprasidone vs Placebo: 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. Ziprasidone vs Placebo: serious adverse events. Trial comparisons, record NCT02075047-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02075047-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 | 0.0349 | 0.0119 | 0.0976 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0432 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0349 | -0.0141 | 0.0976 | 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, for one more participant with a serious adverse event on Ziprasidone than on Placebo | 28.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ziprasidone | Participants were randomized to receive ziprasidone capsules orally once daily for 4 weeks. Dose was titrated over the first 7-14 days of treatment, and the stable dose was maintained for remaining treatment period. Participants with body weight less than 45 kilogram (kg) received 60 to 80 milligram per day (mg/day) and participants with body weight greater than or equal to (\>=) 45 kg received 120 to 160 mg/day, as per investigator discretion. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726). | 3 | 86 | EG000 |
| Group 2 | Placebo | Participants were randomized to receive placebo capsules matched to ziprasidone once daily for 4 weeks. Participants after completion or discontinuation of treatment were followed-up to 35 days (5 weeks) after last dose in this study or were eligible to enroll in open label extension study A1281201 (NCT03768726). | 0 | 85 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Screening (2 Weeks prior to Day 1) up to maximum of 5 Weeks after administration of the final dose of study medication (maximum up to 11 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
- NCT number
- NCT02075047
- Phases
- PHASE3
- Conditions
- Bipolar Disorder
- Interventions
- placebo oral capsules, ziprasidone oral capsules
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2021-04-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02075047?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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