Comparison · NCT00233363-sae
Rebamipide 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. Rebamipide vs Placebo: serious adverse events. Trial comparisons, record NCT00233363-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00233363-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 | 0.0189 | 0.00334 | 0.0994 | wilson | |
| Risk in group 2 | 0.0196 | 0.00347 | 0.103 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00074 | -0.0856 | 0.0814 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.962 | 0.0618 | 15 | log | |
| Odds ratio, group 1 over group 2 | 0.962 | 0.0585 | 15.8 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rebamipide than on Placebo | 1,350 | 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 | Rebamipide | A rebamipide 100 mg tablet was administered orally three times a day for eight weeks. | 1 | 53 | EG000 |
| Group 2 | Placebo | A placebo tablet was administered orally three times a day for eight weeks. | 1 | 51 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
- NCT number
- NCT00233363
- Phases
- PHASE2
- Conditions
- Xerostomia, Sjogren's Syndrome
- Interventions
- Rebamipide
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Results first posted
- 2021-06-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00233363?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00233363-sae