Comparison · NCT02073279-5ff4f2ce
Satralizumab, Then Satralizumab vs Placebo, Then Satralizumab: Number of Participants With at Least One Adverse Event in the DB Period
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. Satralizumab, Then Satralizumab vs Placebo, Then Satralizumab: Number of Participants With at Least One Adverse Event in the DB Period. Trial comparisons, record NCT02073279-5ff4f2ce. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02073279-5ff4f2ce
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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 | 0.921 | 0.827 | 0.966 | wilson | |
| Risk in group 2 | 0.75 | 0.579 | 0.867 | wilson | |
| Risk difference, group 1 minus group 2 | 0.171 | 0.0206 | 0.348 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 0.992 | 1.52 | log | |
| Odds ratio, group 1 over group 2 | 3.87 | 1.15 | 13 | log | |
| Number needed to treat, for one more participant with the outcome on Satralizumab, Then Satralizumab than on Placebo, Then Satralizumab | 5.86 | 2.88 | 48.6 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Satralizumab, Then Satralizumab | Participants received satralizumab 120 mg subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period. Participants who experienced a protocol defined relapse could continue in the Open Label Extension (OLE) period 31 days after relapse. Participants who completed the DB period without relapse could participate in the OLE period 4 weeks after receiving their last dose in the DB period. All OLE participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter. | 58 | 63 | OG001 |
| Group 2 | Placebo, Then Satralizumab | Participants received matching placebo, subcutaneous (SC) injection at Weeks 0, 2 and 4, and every 4 weeks (Q4W) thereafter throughout the double-blind (DB) period up to protocol-defined relapse. Following the DB period, all participants received satralizumab 120 mg SC injection at Weeks 0, 2 and 4, and Q4W thereafter up to the clinical cut-off date (CCOD). At the CCOD, participants who had not experienced a relapse during the DB period were invited to initiate satralizumab 120 mg SC injection (at Weeks 0, 2 and 4, and Q4W thereafter) after 4 weeks from their last study treatment dose in the DB period. | 24 | 32 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With at Least One Adverse Event in the DB Period
- Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
- Time frame
- Up to Week 216
- Population
- The Safety Analysis Population (SAF) included all randomized participants who had received at least 1 dose of satralizumab or placebo.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
- NCT number
- NCT02073279
- Phases
- PHASE3
- Conditions
- Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)
- Interventions
- Satralizumab, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2020-12-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02073279?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT02073279-5ff4f2ce