Comparison · NCT01868997-sae
Safety Population: Teprotumumab vs Safety Population: 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. Safety Population: Teprotumumab vs Safety Population: Placebo: serious adverse events. Trial comparisons, record NCT01868997-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01868997-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 | 0.116 | 0.0507 | 0.245 | wilson | |
| Risk in group 2 | 0.0227 | 0.00402 | 0.118 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0936 | -0.0222 | 0.223 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 5.12 | 0.623 | 42 | log | |
| Odds ratio, group 1 over group 2 | 5.66 | 0.633 | 50.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Safety Population: Teprotumumab than on Safety Population: Placebo | 10.7 | 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 | Safety Population: Teprotumumab | Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants started treatment at a dose of 10 mg/kg. At Week 3, the dose was escalated to 20 mg/kg and kept constant for the remainder of the study.~Safety Population: participants who received at least 1 dose of study treatment, grouped by treatment actually received. | 5 | 43 | EG001 |
| Group 2 | Safety Population: Placebo | A placebo infusion (normal saline) was administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions.~Safety Population: participants who received at least 1 dose of study treatment, grouped by treatment actually received. | 1 | 44 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 72
Source ClinicalTrials.gov
Trial
- Title
- Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
- NCT number
- NCT01868997
- Phases
- PHASE2
- Conditions
- Thyroid Associated Ophthalmopathies, Thyroid-Associated Ophthalmopathy
- Interventions
- teprotumumab, normal saline
- Lead sponsor
- Amgen
- Results first posted
- 2017-08-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01868997?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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