Comparison · NCT03923738-sae
TCZ IV 7 mg/kg Q4W vs TCZ IV 6 mg/kg Q4W: 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. TCZ IV 7 mg/kg Q4W vs TCZ IV 6 mg/kg Q4W: serious adverse events. Trial comparisons, record NCT03923738-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03923738-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 | 0.125 | 0.0434 | 0.31 | wilson | |
| Risk in group 2 | 0.0455 | 0.00807 | 0.218 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0795 | -0.111 | 0.268 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.75 | 0.308 | 24.5 | log | |
| Odds ratio, group 1 over group 2 | 3 | 0.288 | 31.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on TCZ IV 7 mg/kg Q4W than on TCZ IV 6 mg/kg Q4W | 12.6 | 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 | TCZ IV 7 mg/kg Q4W | Participants with GCA who received at least 5 consecutive doses of 8 mg/kg TCZ prior to baseline and reached remission received 5 or 6 consecutive doses of 7 mg/kg IV TCZ Q4W (Period 1). | 3 | 24 | EG000 |
| Group 2 | TCZ IV 6 mg/kg Q4W | Participants that completed Period 1 and were in remission received 5 or 6 consecutive doses of 6 mg/kg IV TCZ Q4W (Period 2). | 1 | 22 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline - Day 151
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
- NCT number
- NCT03923738
- Phases
- PHASE1
- Conditions
- Giant Cell Arteritis
- Interventions
- Tocilizumab
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2021-12-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03923738?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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