Comparison · NCT02921971-sae
SAR156597 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. SAR156597 vs Placebo: serious adverse events. Trial comparisons, record NCT02921971-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02921971-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 | 0.0833 | 0.0329 | 0.196 | wilson | |
| Risk in group 2 | 0.102 | 0.0444 | 0.218 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0187 | -0.145 | 0.107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.817 | 0.233 | 2.86 | log | |
| Odds ratio, group 1 over group 2 | 0.8 | 0.201 | 3.18 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on SAR156597 than on Placebo | 53.5 | 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 | SAR156597 | SAR156597 200 mg single SC injection QW up to Week 24. | 4 | 48 | EG001 |
| Group 2 | Placebo | Placebo (for SAR156597), single SC injection QW up to Week 24. | 5 | 49 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events (AEs) were collected from the signature of the informed consent form until the end of the study, regardless of seriousness or relationship to investigational medicinal product (IMP). Reported treatment-emergent adverse events (TEAEs) and deaths were AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP up to 12 weeks (84 days) from the last dose of IMP (i.e. up to 36 weeks).
Source ClinicalTrials.gov
Trial
- Title
- Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
- NCT number
- NCT02921971
- Phases
- PHASE2
- Conditions
- Systemic Sclerosis
- Interventions
- SAR156597, Placebo
- Lead sponsor
- Sanofi
- Results first posted
- 2022-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02921971?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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