Comparison · NCT03298867-sae
Teprotumumab 20 mg/kg 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 20 mg/kg vs Placebo: serious adverse events. Trial comparisons, record NCT03298867-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03298867-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 | 0.0488 | 0.0135 | 0.161 | wilson | |
| Risk in group 2 | 0.0238 | 0.00422 | 0.123 | wilson | |
| Risk difference, group 1 minus group 2 | 0.025 | -0.0805 | 0.139 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.05 | 0.193 | 21.7 | log | |
| Odds ratio, group 1 over group 2 | 2.1 | 0.183 | 24.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Teprotumumab 20 mg/kg than on Placebo | 40 | 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 20 mg/kg | Eight infusions of teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg administered on Day 1 and teprotumumab 20 mg/kg administered q3W for the remaining 7 infusions. | 2 | 41 | EG001 |
| Group 2 | Placebo | Eight infusions of placebo q3W for a total of 21 weeks. | 1 | 42 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug through the end of the Double-Masked Treatment Period (up to 24 weeks) plus 3 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
- NCT number
- NCT03298867
- Phases
- PHASE3
- Conditions
- Thyroid Eye Disease, Graves' Orbitopathy
- Interventions
- Teprotumumab, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2020-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03298867?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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