Comparison · NCT01106014-sae
Selexipag 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. Selexipag vs Placebo: serious adverse events. Trial comparisons, record NCT01106014-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01106014-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 | 0.438 | 0.398 | 0.479 | wilson | |
| Risk in group 2 | 0.471 | 0.431 | 0.512 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0331 | -0.0903 | 0.0243 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.93 | 0.819 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.875 | 0.694 | 1.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Selexipag than on Placebo | 30.2 | 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 | Selexipag | This group includes patients who received at least one dose of selexipag. One subject who was randomized to placebo received a single dose of 8 tablets of selexipag due to an error in the dispensation of the medication bottle. Therefore, this patient was assigned to the selexipag group in the safety analysis set. | 252 | 575 | EG000 |
| Group 2 | Placebo | This group includes patients who received at least one dose of placebo. Four patients who were randomized to placebo never received the drugs and another patient received selexipag by mistake (see Selexipag group for more details). Therefore, these patients were excluded from the placebo group in the safety analysis set. | 272 | 577 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From baseline up to up to 7 days after end of treatment (EOT)
Source ClinicalTrials.gov
Trial
- Title
- Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
- NCT number
- NCT01106014
- Phases
- PHASE3
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Selexipag, Placebo
- Lead sponsor
- Actelion
- Results first posted
- 2016-03-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01106014?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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