Comparison · NCT01605136-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 NCT01605136-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01605136-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 | 0.0625 | 0.0215 | 0.168 | wilson | |
| Risk in group 2 | 0.0444 | 0.0123 | 0.148 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0181 | -0.0936 | 0.129 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.41 | 0.246 | 8.03 | log | |
| Odds ratio, group 1 over group 2 | 1.43 | 0.228 | 9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Afamelanotide than on Placebo | 55.4 | 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 | One 16mg subcutaneous implant every 2 months for 6 months.~Afamelanotide: One 16mg subcutaneous implant every 2 months for 6 months. | 3 | 48 | EG000 |
| Group 2 | Placebo | One placebo subcutaneous implant every 2 months for 6 months.~Placebo: One placebo subcutaneous implant every 2 months for 6 months | 2 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Visit 1 (Day 0) - Visit 4 (Day 180)
Source ClinicalTrials.gov
Trial
- Title
- Phase III Confirmatory Study in Erythropoietic Protoporphyria
- NCT number
- NCT01605136
- Phases
- PHASE3
- Conditions
- Erythropoietic Protoporphyria
- Interventions
- Afamelanotide, Placebo
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Results first posted
- 2019-08-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01605136?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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