Comparison · NCT04051944-9e778f75
Rozanolixizumab (Newly Treated) vs Rozanolixizumab (Previously Treated): Number of Participants With Treatment-emergent Adverse Event (TEAEs)
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. Rozanolixizumab (Newly Treated) vs Rozanolixizumab (Previously Treated): Number of Participants With Treatment-emergent Adverse Event (TEAEs). Trial comparisons, record NCT04051944-9e778f75. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04051944-9e778f75
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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 | 0.909 | 0.623 | 0.984 | wilson | |
| Risk in group 2 | 1 | 0.722 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0909 | -0.377 | 0.196 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.909 | 0.754 | 1.1 | log | |
| 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 Rozanolixizumab (Newly Treated) than on Rozanolixizumab (Previously Treated) | 11 | 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 | Rozanolixizumab (Newly Treated) | Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. | 10 | 11 | OG000 |
| Group 2 | Rozanolixizumab (Previously Treated) | Participants received rozanolixizumab Dose A as a subcutaneous infusion once weekly up to Week 76. | 10 | 10 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Treatment-emergent Adverse Event (TEAEs)
- Description
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily had a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE was defined as any event that was not present prior the first administration of investigational medicinal product (IMP) in CIDP04 study or any unresolved event already present before the first administration of IMP in CIDP04 study that worsened in intensity following exposure to treatment until 8 weeks following the last administration of IMP in CIDP04 study.
- Time frame
- From Baseline until Follow-Up Visit (up to Week 84)
- Population
- The Safety Set (SS) consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- NCT number
- NCT04051944
- Phases
- PHASE2
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Interventions
- Rozanolixizumab
- Lead sponsor
- UCB Biopharma SRL
- Results first posted
- 2022-11-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04051944?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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