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 |
|---|---|---|---|---|---|---|---|---|
| Placebo - Treatment Phase | Placebo given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 0 | 137 | 23 | 137 | View |
| 5mg Galcanezumab-Treatment Phase | 5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 0 | 68 | 20 | 68 | View |
| 50mg Galcanezumab-Treatment Phase | 50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 0 | 68 | 18 | 68 | View |
| 120mg Galcanezumab-Treatment Phase | 120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 1 | 70 | 23 | 70 | View |
| 300mg Galcanezumab-Treatment Phase | 300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 1 | 67 | 19 | 67 | View |
| Placebo - Post-Treatment Phase | Placebo given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 0 | 125 | 6 | 125 | View |
| 5mg Galcanezumab-Post-Treatment Phase | 5mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 1 | 61 | 2 | 61 | View |
| 50mg Galcanezumab-Post-Treatment Phase | 50mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 0 | 66 | 2 | 66 | View |
| 120mg Galcanezumab-Post-Treatment Phase | 120mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 0 | 63 | 2 | 63 | View |
| 300mg Galcanezumab-Post-Treatment Phase | 300mg of galcanezumab given as SQ injections once every 28 days during a 12 week treatment period. | None | None | 1 | 65 | 3 | 65 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 17.1 | View |
| Ankyloglossia Congenital | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 17.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 17.1 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 17.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 17.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 17.1 | View |