Comparison · NCT03436797-sae
AK002 Main Study vs AK002 Extended Dosing: 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. AK002 Main Study vs AK002 Extended Dosing: serious adverse events. Trial comparisons, record NCT03436797-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03436797-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 | 0.0851 | 0.0336 | 0.199 | wilson | |
| Risk in group 2 | 0.2 | 0.0362 | 0.624 | wilson | |
| Risk difference, group 1 minus group 2 | -0.115 | -0.542 | 0.0848 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.426 | 0.0583 | 3.11 | log | |
| Odds ratio, group 1 over group 2 | 0.372 | 0.0331 | 4.18 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on AK002 Main Study than on AK002 Extended Dosing | 8.7 | 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 | AK002 Main Study | This arm included all subjects who were enrolled in the Main Study Phase | 4 | 47 | EG000 |
| Group 2 | AK002 Extended Dosing | This arm included all subjects from the main study who were enrolled in the Extended Dosing Phase | 1 | 5 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria
- NCT number
- NCT03436797
- Phases
- PHASE2
- Conditions
- Chronic Urticaria
- Interventions
- AK002
- Lead sponsor
- Allakos Inc.
- Results first posted
- 2024-01-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03436797?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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