Comparison · NCT02213094-fe6276bd
Nicotinamide 500 mg vs Nicotinamide 1000 mg: Number of Participants With 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. Nicotinamide 500 mg vs Nicotinamide 1000 mg: Number of Participants With Adverse Events. Trial comparisons, record NCT02213094-fe6276bd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02213094-fe6276bd
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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 | 0.4 | 0.118 | 0.769 | wilson | |
| Risk in group 2 | 0 | 0 | 0.434 | wilson | |
| Risk difference, group 1 minus group 2 | 0.4 | -0.118 | 0.769 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Nicotinamide 500 mg than on Nicotinamide 1000 mg | 2.5 | 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 | Nicotinamide 500 mg | Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first. | 2 | 5 | OG000 |
| Group 2 | Nicotinamide 1000 mg | Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first. | 0 | 5 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Adverse Events
- Description
Specific adverse events were Maternal liver toxicity, defined as \> 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.
- Time frame
- Within 48 hours of dosing
- Population
Source ClinicalTrials.gov
Trial
- Title
- Phase I Study of Nicotinamide for Early Onset Preeclampsia
- NCT number
- NCT02213094
- Phases
- PHASE1
- Conditions
- Pregnancy Induced Hypertension, Superimposed Preeclampsia, Hypertension
- Interventions
- Nicotinamide 500 mg, Nicotinamide 1000 mg
- Lead sponsor
- University of North Carolina, Chapel Hill
- Results first posted
- 2018-11-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02213094?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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