Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| AK002 SC 300 mg (Main Study) | Subjects in this arm received up to 6 doses of 300 mg of lirentelimab (AK002) administered subcutaneously every 2 weeks in the main study. AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8 | 0 | None | 1 | 66 | 26 | 66 | View |
| Placebo (Main Study) | Subjects in this arm received up to 6 doses of placebo administered subcutaneously every 2 weeks in the main study. Placebo: Placebo | 0 | None | 1 | 61 | 18 | 61 | View |
| AK002 Continuing (OLE) | Subjects in this arm received AK002 in the main study and continued to receive up to 6 doses of 300 mg AK002 SC in the open-label extension (OLE) period. AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8 | 0 | None | 2 | 60 | 22 | 60 | View |
| Placebo Rollover (OLE) | Subjects in this arm received placebo in the main study and rolled over to receive up to 6 doses of 300 mg AK002 SC in the open-label extension (OLE) period. Placebo: Placebo AK002: Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8 | 0 | None | 2 | 57 | 19 | 57 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Epiglottitis obstructive | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE 5.0 | View |
| Gun shot wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 5.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 5.0 | View |
| Hemiparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 5.0 | View |
| Bipolar disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 5.0 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 5.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 5.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Injection related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 5.0 | View |
| Chronic spontaneous urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 5.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 5.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 5.0 | View |