Comparison · NCT01305408-sae
Armodafinil 150 mg/Day 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
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ConductScience Library. Armodafinil 150 mg/Day vs Placebo: serious adverse events. Trial comparisons, record NCT01305408-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01305408-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 | 0.025 | 0.0107 | 0.0572 | wilson | |
| Risk in group 2 | 0.0303 | 0.014 | 0.0645 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0053 | -0.0424 | 0.0308 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.825 | 0.256 | 2.66 | log | |
| Odds ratio, group 1 over group 2 | 0.821 | 0.246 | 2.73 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Armodafinil 150 mg/Day than on Placebo | 189 | 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 | Armodafinil 150 mg/Day | Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks. | 5 | 200 | EG000 |
| Group 2 | Placebo | Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks. | 6 | 198 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 to Week 9
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
- NCT number
- NCT01305408
- Phases
- PHASE3
- Conditions
- Depression
- Interventions
- Armodafinil, Placebo
- Lead sponsor
- Cephalon
- Results first posted
- 2015-01-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01305408?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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