Comparison · NCT00257166-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
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ConductScience Library. Ziprasidone vs Placebo: serious adverse events. Trial comparisons, record NCT00257166-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00257166-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 | 0.0403 | 0.0186 | 0.0851 | wilson | |
| Risk in group 2 | 0.0795 | 0.0391 | 0.155 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0393 | -0.118 | 0.0211 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.506 | 0.176 | 1.46 | log | |
| Odds ratio, group 1 over group 2 | 0.486 | 0.158 | 1.49 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ziprasidone than on Placebo | 25.5 | 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 | Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to \[\>=\] 45 kilogram \[kg\] weight and ziprasidone 60 to 80 mg/day for participants with less than \[\<\] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with \>= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with \<45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion. | 6 | 149 | EG000 |
| Group 2 | Placebo | Placebo matched to ziprasidone capsule orally twice daily up to Week 4. | 7 | 88 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
- NCT number
- NCT00257166
- Phases
- PHASE3
- Conditions
- Bipolar Disorder
- Interventions
- Ziprasidone oral capsules, placebo oral capsules
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2013-07-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00257166?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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