Comparison · NCT01379469-sae
Drug-Carbamazepine (Tegretol XR) vs Drug-Carbamazepine (Tegretol XR) 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. Drug-Carbamazepine (Tegretol XR) vs Drug-Carbamazepine (Tegretol XR) Placebo: serious adverse events. Trial comparisons, record NCT01379469-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01379469-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 | 0.462 | 0.232 | 0.709 | wilson | |
| Risk in group 2 | 0.571 | 0.25 | 0.842 | wilson | |
| Risk difference, group 1 minus group 2 | -0.11 | -0.465 | 0.295 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.808 | 0.338 | 1.93 | log | |
| Odds ratio, group 1 over group 2 | 0.643 | 0.101 | 4.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Drug-Carbamazepine (Tegretol XR) than on Drug-Carbamazepine (Tegretol XR) Placebo | 9.1 | 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 | Drug-Carbamazepine (Tegretol XR) | One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Drug-Carbamazepine (Tegretol XR): To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated, and the placebo group will receive encapsulated tablets without CBZ. | 6 | 13 | EG000 |
| Group 2 | Drug-Carbamazepine (Tegretol XR) Placebo | One arm receives Carbamazepine (Tegretol-XR) placebo.All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.~Carbamazepine (Tegretol XR) Placebo: Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine. | 4 | 7 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious Adverse Events and Adverse Events were collected for 52 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Carbamazepine in Severe Liver Disease Due to Alpha-1 Antitrypsin Deficiency
- NCT number
- NCT01379469
- Phases
- PHASE2
- Conditions
- Alpha-1-antitrypsin Deficiency, Liver Cirrhosis
- Interventions
- Drug-Carbamazepine (Tegretol XR), Carbamazepine (Tegretol XR) Placebo
- Lead sponsor
- Washington University School of Medicine
- Results first posted
- 2021-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01379469?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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