Comparison · NCT01404078-sae
Two Doses of Low Strength Polycap vs One Dose of Low Srength Polycap: 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. Two Doses of Low Strength Polycap vs One Dose of Low Srength Polycap: serious adverse events. Trial comparisons, record NCT01404078-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01404078-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 | 0.035 | 0.0185 | 0.0652 | wilson | |
| Risk in group 2 | 0.00383 | 0.000677 | 0.0214 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0312 | 0.00711 | 0.0615 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 9.14 | 1.17 | 71.6 | log | |
| Odds ratio, group 1 over group 2 | 9.44 | 1.19 | 75 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Two Doses of Low Strength Polycap than on One Dose of Low Srength Polycap | 32.1 | 16.3 | 141 | from the risk difference interval |
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 | Two Doses of Low Strength Polycap | Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin | 9 | 257 | EG000 |
| Group 2 | One Dose of Low Srength Polycap | Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin | 1 | 261 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
- NCT number
- NCT01404078
- Phases
- NA
- Conditions
- Ischemic Heart Disease, Ischemic Stroke, Peripheral Vascular Disease, Type 2 Diabetes Mellitus
- Interventions
- Single Dose Polycap, Double dose Polycap
- Lead sponsor
- St. John's Research Institute
- Results first posted
- 2014-12-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01404078?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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