Comparison · NCT03664960-sae
Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 vs Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002: 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. Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 vs Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002: serious adverse events. Trial comparisons, record NCT03664960-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03664960-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 | 0.243 | 0.134 | 0.401 | wilson | |
| Risk in group 2 | 0.0952 | 0.0265 | 0.289 | wilson | |
| Risk difference, group 1 minus group 2 | 0.148 | -0.0747 | 0.32 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.55 | 0.608 | 10.7 | log | |
| Odds ratio, group 1 over group 2 | 3.05 | 0.593 | 15.7 | log | |
Number needed to harm, for one more participant with a serious adverse event on Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 than on Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | 6.76 | 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 | Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects in this arm received the active drug in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.~AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | 9 | 37 | EG001 |
| Group 2 | Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002 | Subjects in this arm received the placebo in the main study (AK002-003) and were treated with 26 monthly doses of AK002: a first dose of 1 mg/kg, followed by monthly doses of 3 mg/kg.~AK002: AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8. | 2 | 21 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through study completion, up to 28 months
Source ClinicalTrials.gov
Trial
- Title
- An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
- NCT number
- NCT03664960
- Phases
- PHASE2
- Conditions
- Eosinophilic Gastritis, Eosinophilic Gastroenteritis, Eosinophilic Duodenitis
- Interventions
- AK002
- Lead sponsor
- Allakos Inc.
- Results first posted
- 2024-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03664960?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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