Comparison · NCT04541589-sae
Arm 1: Iscalimab 600 mg vs Arm 2 - Iscalimab 300 mg: 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. Arm 1: Iscalimab 600 mg vs Arm 2 - Iscalimab 300 mg: serious adverse events. Trial comparisons, record NCT04541589-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04541589-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 | 0.0855 | 0.0507 | 0.141 | wilson | |
| Risk in group 2 | 0.037 | 0.0102 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0485 | -0.0465 | 0.11 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.31 | 0.538 | 9.9 | log | |
| Odds ratio, group 1 over group 2 | 2.43 | 0.531 | 11.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm 1: Iscalimab 600 mg than on Arm 2 - Iscalimab 300 mg | 20.6 | 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 | Arm 1: Iscalimab 600 mg | Participants received 600 mg (2 injections of 300 mg/2 mL) of iscalimab subcutaneously weekly for the initial 3 weeks as loading doses, followed by a bi-weekly maintenance regimen at 600 mg (2 injections of 300 mg/2 mL). | 13 | 152 | EG000 |
| Group 2 | Arm 2 - Iscalimab 300 mg | Participants received one dose of 600 mg (2 injections of 300 mg/2 mL) of iscalimab subcutaneously on the first day of the extension study; then 300 mg weekly (1 injection of 300 mg/2 mL of iscalimab and 1 injection of 2 mL of placebo) for the next 2 weeks as loading doses. This was followed by a bi-weekly maintenance regimen of 300 mg (1 injection of 300 mg/2 mL of iscalimab and 1 injection of 2 mL of placebo). After the final database lock of the core study, participants underwent unblinding, leading to the discontinuation of placebo injections. | 2 | 54 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of extension study up to 14 weeks after last study-drug administration or end of study (whichever occurred earlier), assessed up to approximately 60 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome
- NCT number
- NCT04541589
- Phases
- PHASE2
- Conditions
- Sjogren's Syndrome
- Interventions
- Iscalimab, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2025-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04541589?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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