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Comparison · NCT01529268-deaths

DR Cysteamine Bitartrate Capsule vs DR Cysteamine Bitartrate Placebo: deaths from any cause

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. DR Cysteamine Bitartrate Capsule vs DR Cysteamine Bitartrate Placebo: deaths from any cause. Trial comparisons, record NCT01529268-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01529268-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0418wilson
Risk in group 2000.0453wilson
Risk difference, group 1 minus group 20-0.04530.0418newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1DR 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
088EG000
Group 2DR 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
081EG001

Harm

What it counts
Total, all-cause mortality
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

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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