Comparison · NCT01529268-sae
DR Cysteamine Bitartrate Capsule vs DR Cysteamine Bitartrate 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. DR Cysteamine Bitartrate Capsule vs DR Cysteamine Bitartrate Placebo: serious adverse events. Trial comparisons, record NCT01529268-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01529268-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 | 0.0568 | 0.0245 | 0.126 | wilson | |
| Risk in group 2 | 0.0494 | 0.0194 | 0.12 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00744 | -0.0704 | 0.083 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.32 | 4.14 | log | |
| Odds ratio, group 1 over group 2 | 1.16 | 0.3 | 4.48 | log | |
| Number needed to harm, for one more participant with a serious adverse event on DR Cysteamine Bitartrate Capsule than on DR Cysteamine Bitartrate Placebo | 134 | 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 | DR Cysteamine Bitartrate Capsule | Active DR cysteamine bitartrate capsule~DR cysteamine bitartrate capsule: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~* 750 mg/day (five 75 mg capsules twice daily) for patients \>65 - 80 kg at baseline~* 900 mg/day (six 75 mg capsules twice daily) for patients \>80 kg at baseline | 5 | 88 | EG000 |
| Group 2 | DR Cysteamine Bitartrate Placebo | Placebo DR cysteamine bitartrate capsule~DR cysteamine bitartrate placebo: ◦ 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline~* 750 mg/day (five 75 mg capsules twice daily) for patients \>65 - 80 kg at baseline~* 900 mg/day (six 75 mg capsules twice daily) for patients \>80 kg at baseline | 4 | 81 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 52 weeks
Source ClinicalTrials.gov
Trial
- Title
- Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children
- NCT number
- NCT01529268
- Phases
- PHASE2, PHASE3
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Interventions
- DR cysteamine bitartrate capsule, DR cysteamine bitartrate placebo
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Results first posted
- 2017-09-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01529268?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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