Comparison · NCT03478930-sae
Received Omalizumab in GA39688 or GA39855 vs Received Placebo in GA39688 or GA39855: 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. Received Omalizumab in GA39688 or GA39855 vs Received Placebo in GA39688 or GA39855: serious adverse events. Trial comparisons, record NCT03478930-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03478930-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 | 0.0645 | 0.0331 | 0.122 | wilson | |
| Risk in group 2 | 0.096 | 0.0558 | 0.16 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0315 | -0.103 | 0.0388 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.672 | 0.285 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 0.649 | 0.256 | 1.65 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Received Omalizumab in GA39688 or GA39855 than on Received Placebo in GA39688 or GA39855 | 31.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Received Omalizumab in GA39688 or GA39855 | After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies. | 8 | 124 | EG001 |
| Group 2 | Received Placebo in GA39688 or GA39855 | After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies. | 12 | 125 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Start to End (Weeks 24 to 76) of OLE Study
Source ClinicalTrials.gov
Trial
- Title
- An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
- NCT number
- NCT03478930
- Phases
- PHASE3
- Conditions
- Nasal Polyps, Chronic Rhinosinusitis
- Interventions
- Omalizumab, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2021-05-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03478930?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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