Comparison · NCT01813019-sae
AFQ056 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
Cite this record
ConductScience Library. AFQ056 vs Placebo: serious adverse events. Trial comparisons, record NCT01813019-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01813019-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 | 0.0385 | 0.00682 | 0.189 | wilson | |
| Risk in group 2 | 0.0833 | 0.0232 | 0.258 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0449 | -0.223 | 0.117 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.462 | 0.0447 | 4.77 | log | |
| Odds ratio, group 1 over group 2 | 0.44 | 0.0373 | 5.19 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on AFQ056 than on Placebo | 22.3 | 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 | AFQ056 | AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks | 1 | 26 | EG001 |
| Group 2 | Placebo | Matching Placebo b.i.d. dosing | 2 | 24 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder (OCD) Patients Resistant to Selective Serotonin Reuptake Inhibitor (SSRI) Therapy
- NCT number
- NCT01813019
- Phases
- PHASE2
- Conditions
- Patient Diagnosed With OCD and Resistant to SSRI Treatment, Failed SSRI Over 12 Weeks at Appropriate Doses
- Interventions
- AFQ056, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2016-07-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01813019?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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