Comparison · NCT00669955-sae
Quadruple Therapy (OBMT) 10 Days vs Triple Therapy (OAC) 7 Days: 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. Quadruple Therapy (OBMT) 10 Days vs Triple Therapy (OAC) 7 Days: serious adverse events. Trial comparisons, record NCT00669955-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00669955-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 | 0.0185 | 0.00722 | 0.0466 | wilson | |
| Risk in group 2 | 0.0135 | 0.00461 | 0.039 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00501 | -0.0228 | 0.0345 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.37 | 0.31 | 6.05 | log | |
| Odds ratio, group 1 over group 2 | 1.38 | 0.305 | 6.23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Quadruple Therapy (OBMT) 10 Days than on Triple Therapy (OAC) 7 Days | 200 | from the risk difference interval | the interval includes no difference |
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 | Quadruple Therapy (OBMT) 10 Days | Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day) | 4 | 216 | EG000 |
| Group 2 | Triple Therapy (OAC) 7 Days | Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID | 3 | 222 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
- NCT number
- NCT00669955
- Phases
- PHASE3
- Conditions
- Helicobacter Infections
- Interventions
- Omeprazole, amoxicillin, clarithromycin, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
- Lead sponsor
- Forest Laboratories
- Results first posted
- 2010-08-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00669955?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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