Comparison · NCT03469349-sae
Actovegin 1200 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. Actovegin 1200 mg vs Placebo: serious adverse events. Trial comparisons, record NCT03469349-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03469349-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 | 0.0489 | 0.0259 | 0.0903 | wilson | |
| Risk in group 2 | 0.0165 | 0.00562 | 0.0473 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0324 | -0.00603 | 0.0752 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.97 | 0.816 | 10.8 | log | |
| Odds ratio, group 1 over group 2 | 3.07 | 0.817 | 11.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Actovegin 1200 mg than on Placebo | 30.8 | 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 | Actovegin 1200 mg | Actovegin 1200 mg, infusion, intravenously, once daily for up to 2 weeks followed by actovegin 200 mg, tablets, orally, thrice daily (1200 mg/day) for up to 10 weeks. | 9 | 184 | EG001 |
| Group 2 | Placebo | Actovegin placebo-matching infusion, intravenously, once daily for up to 2 weeks followed by actovegin placebo-matching tablets, orally, thrice daily for up to 10 weeks. | 3 | 182 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug up to Day 168
Source ClinicalTrials.gov
Trial
- Title
- Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
- NCT number
- NCT03469349
- Phases
- PHASE3
- Conditions
- Peripheral Arterial Diseases
- Interventions
- Actovegin, Placebo
- Lead sponsor
- Takeda
- Results first posted
- 2020-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03469349?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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