Comparison · NCT01097044-sae
Afamelanotide 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. Afamelanotide vs Placebo: serious adverse events. Trial comparisons, record NCT01097044-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01097044-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 | 0.0513 | 0.0142 | 0.169 | wilson | |
| Risk in group 2 | 0.0526 | 0.0146 | 0.173 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00135 | -0.127 | 0.122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.974 | 0.145 | 6.57 | log | |
| Odds ratio, group 1 over group 2 | 0.973 | 0.13 | 7.28 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Afamelanotide than on Placebo | 741 | 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 | Afamelanotide | Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total) | 2 | 39 | EG000 |
| Group 2 | Placebo | Placebo: One placebo subcutaneous implant every 2 months for 6 months. (3 implants in total) | 2 | 38 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 months (180 days)
Source ClinicalTrials.gov
Trial
- Title
- Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)
- NCT number
- NCT01097044
- Phases
- PHASE2
- Conditions
- Erythropoietic Protoporphyria
- Interventions
- Afamelanotide, Placebo
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Results first posted
- 2019-09-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01097044?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT01097044-sae