Comparison · NCT02075047-b4ae2abd
Ziprasidone vs Placebo: Number of Participants With Laboratory Abnormalities
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: Number of Participants With Laboratory Abnormalities. Trial comparisons, record NCT02075047-b4ae2abd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02075047-b4ae2abd
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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 | 0.595 | 0.488 | 0.694 | wilson | |
| Risk in group 2 | 0.747 | 0.644 | 0.828 | wilson | |
| Risk difference, group 1 minus group 2 | -0.152 | -0.286 | -0.00918 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.797 | 0.642 | 0.989 | log | |
| Odds ratio, group 1 over group 2 | 0.498 | 0.258 | 0.963 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ziprasidone than on Placebo | 6.59 | 3.5 | 109 | from the risk difference interval |
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). | 50 | 84 | OG000 |
| 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). | 62 | 83 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Laboratory Abnormalities
- Description
Criteria: Hematology-hemoglobin(Hg),hematocrit,erythrocytes(ery)\<0.8\*LLN,ery mean corpuscular volume \<0.9\*LLN\>1.1\*ULN,platelets\<0.5\*LLN\>1.75\*ULN,leukocytes(leu)\<0.6\*LLN\>1.5\*ULN,lymphocytes(lym),lym/leu,neutrophils(neu),neu/leu\<0.8\*LLN\>1.2\*ULN,basophils (bas),bas/leu, eosinophils(eos), eos/leu, monocytes(mon),mon/leu\>1.2\*ULN; Clinical chemistry bilirubin: total, direct, indirect\>1.5\*ULN, aspartate aminotransferase,alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase,alkaline phosphatase\>3.0\*ULN,protein,albumin\<0.8\*LLN\>1.2\*ULN,blood urea nitrogen,creatinine\>1.3\*ULN, urate\>1.2\*ULN,HDL\<0.8\*LLN;LDL\>1.2\*ULN cholesterol(CH),sodium\<0.95\*LLN\>1.05\*ULN,potassium, chloride,calcium,magnesium,bicarbonate\<0.9\*LLLN\>1.1\*ULN,phosphate,free thyroxine,thyroid stimulating hormone\<0.8\*LLN\>1.2\*ULN,prolactin\>1.1\*ULN,glucose\<0.6\*LLN\>1.5\*ULN,HgA1C,CH, triglycerides\>1.3\*ULN,creatine kinase\>2.0\*ULN; Urinalysis-specific gravity\<1.003\>1.030,pH\<4.5 \>8,urine glucose, protein, Hg, ketones:\>=1.
- Time frame
- Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)
- Population
The safety analysis set included all participants who were randomized and took at least 1 dose of study medication (ziprasidone or placebo). Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
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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