Comparison · NCT04583735-sae
Teprotumumab 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. Teprotumumab vs Placebo: serious adverse events. Trial comparisons, record NCT04583735-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04583735-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 | 0.0244 | 0.00432 | 0.126 | wilson | |
| Risk in group 2 | 0.05 | 0.00888 | 0.236 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0256 | -0.213 | 0.084 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.488 | 0.0321 | 7.4 | log | |
| Odds ratio, group 1 over group 2 | 0.475 | 0.0282 | 8.01 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Teprotumumab than on Placebo | 39 | 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 | Teprotumumab | Participants received intravenous infusion of 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period. | 1 | 41 | EG000 |
| Group 2 | Placebo | Participants received teprotumumab matching placebo by intravenous infusion, Q3W for 8 infusions during the double masked treatment period. Proptosis non-responders who completed the double-masked treatment period had opted to receive 10 mg/kg teprotumumab at first infusion and then 20 mg/kg Q3W for next 7 infusions during open label treatment period. | 1 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug until week 24
Source ClinicalTrials.gov
Trial
- Title
- A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
- NCT number
- NCT04583735
- Phases
- PHASE4
- Conditions
- Thyroid Eye Disease, Chronic (Inactive) Thyroid Eye Disease
- Interventions
- TEPEZZA, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2024-04-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04583735?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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