Comparison · NCT04478994-835bd187
TEPEZZA 20 mg/kg vs Placebo: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. TEPEZZA 20 mg/kg vs Placebo: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24. Trial comparisons, record NCT04478994-835bd187. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04478994-835bd187
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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 | 0 | 0.793 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -1 | -1 | 0.0305 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on TEPEZZA 20 mg/kg than on Placebo | 1 | 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 | TEPEZZA 20 mg/kg | Participants receive 8 infusions of TEPEZZA every 3 weeks (q3W) for a total of 21 weeks: TEPEZZA 10 mg/kg administered on Day 1 and TEPEZZA 20 mg/kg administered q3W for the remaining 7 infusions. | 0 | 1 | OG000 |
| Group 2 | Placebo | Participants receive 8 infusions of placebo q3W for a total of 21 weeks. | 2 | 2 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) Through Week 24
- Description
- An adverse event (AE) is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. TEAEs are those that occurred after the first dose of trial drug.
- Time frame
- From first dose of trial drug up to Week 24
- Population
- All randomized participants
Source ClinicalTrials.gov
Trial
- Title
- A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
- NCT number
- NCT04478994
- Phases
- PHASE1
- Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Interventions
- TEPEZZA, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2024-04-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04478994?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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