Comparison · NCT00891046-sae
ACZ885 Treated vs ACZ885 Treatment Naive: 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. ACZ885 Treated vs ACZ885 Treatment Naive: serious adverse events. Trial comparisons, record NCT00891046-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00891046-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 | 0.32 | 0.25 | 0.399 | wilson | |
| Risk in group 2 | 0.325 | 0.249 | 0.412 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00548 | -0.117 | 0.105 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.983 | 0.695 | 1.39 | log | |
| Odds ratio, group 1 over group 2 | 0.975 | 0.584 | 1.63 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ACZ885 Treated than on ACZ885 Treatment Naive | 183 | 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 | ACZ885 Treated | Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4. | 47 | 147 | EG000 |
| Group 2 | ACZ885 Treatment Naive | Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose. | 40 | 123 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study treatment (Day 1) to end of follow-up period (Week 271)
Source ClinicalTrials.gov
Trial
- Title
An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.
- NCT number
- NCT00891046
- Phases
- PHASE3
- Conditions
- Systemic Juvenile Idiopathic Arthritis
- Interventions
- Canakinumab
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2017-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00891046?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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