Comparison · NCT01264939-sae
Omalizumab 300 mg vs Placebo: 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. Omalizumab 300 mg vs Placebo: serious adverse events. Trial comparisons, record NCT01264939-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01264939-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 | 0.0714 | 0.0457 | 0.11 | wilson | |
| Risk in group 2 | 0.0602 | 0.026 | 0.133 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0112 | -0.0664 | 0.0628 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.454 | 3.09 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.431 | 3.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Omalizumab 300 mg than on Placebo | 89.4 | 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 | Omalizumab 300 mg | Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period. | 18 | 252 | EG001 |
| Group 2 | Placebo | Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period. | 5 | 83 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported that started on or after the first treatment date through the end of the study (up to 40 weeks).
Source ClinicalTrials.gov
Trial
- Title
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
- NCT number
- NCT01264939
- Phases
- PHASE3
- Conditions
- Chronic Idiopathic Urticaria
- Interventions
- Omalizumab, Placebo, H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist, Diphenhydramine
- Lead sponsor
- Genentech, Inc.
- Results first posted
- 2013-11-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01264939?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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