Comparison · NCT04422431-sae
Treatment Period: ALXN1840 vs Extension Period: ALXN1840: 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. Treatment Period: ALXN1840 vs Extension Period: ALXN1840: serious adverse events. Trial comparisons, record NCT04422431-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04422431-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 | 0.0968 | 0.0335 | 0.249 | wilson | |
| Risk in group 2 | 0.08 | 0.0222 | 0.25 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0168 | -0.164 | 0.18 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.219 | 6.69 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.189 | 8.01 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Treatment Period: ALXN1840 than on Extension Period: ALXN1840 | 59.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment Period: ALXN1840 | Participants received ALXN1840 orally in the 48-week Treatment Period. | 3 | 31 | EG000 |
| Group 2 | Extension Period: ALXN1840 | Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. | 2 | 25 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
- NCT number
- NCT04422431
- Phases
- PHASE2
- Conditions
- Wilson Disease
- Interventions
- Bis-Choline Tetrathiomolybdate
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Results first posted
- 2023-07-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04422431?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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