Comparison · NCT03548935-sae
Sema 2.4 mg 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. Sema 2.4 mg vs Placebo: serious adverse events. Trial comparisons, record NCT03548935-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03548935-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 | 0.098 | 0.083 | 0.115 | wilson | |
| Risk in group 2 | 0.0641 | 0.0478 | 0.0855 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0339 | 0.00776 | 0.0577 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.53 | 1.09 | 2.14 | log | |
| Odds ratio, group 1 over group 2 | 1.59 | 1.1 | 2.28 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sema 2.4 mg than on Placebo | 29.5 | 17.3 | 129 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sema 2.4 mg | Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 128 | 1,306 | EG000 |
| Group 2 | Placebo | Participants were to receive once-weekly subcutaneous (s.c) injection of 0.25 mg Semaglutide placebo administered using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing Semaglutide placebo 1.0 mg/mL or 3.0 mg/mL and followed a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), aiming at reaching the maintenance dose of 2.4 mg Semaglutide placebo after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | 42 | 655 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of Semaglutide or placebo.
Source ClinicalTrials.gov
Trial
- Title
- STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
- NCT number
- NCT03548935
- Phases
- PHASE3
- Conditions
- Metabolism and Nutrition Disorder, Overweight or Obesity
- Interventions
- Semaglutide, Placebo (semaglutide)
- Lead sponsor
- Novo Nordisk A/S
- Results first posted
- 2021-08-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03548935?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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