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 |
|---|---|---|---|---|---|---|---|---|
| AGN-151586 | Participants received 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, participants may also have received 1 open-label treatment of AGN-151586 on Day 43. | 0 | None | 3 | 482 | 31 | 482 | View |
| Placebo/None | Participants received placebo injections during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit. | 0 | None | 0 | 3 | 0 | 3 | View |
| Placebo/AGN-151586 | Participants received placebo injections during the Double-blind Period and met all the retreatment criteria on Day 43. A single open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84). | 0 | None | 0 | 145 | 8 | 145 | View |
| AGN-151586/None | Participants received AGN-151586 during the Double-blind Period but did not meet all the retreatment criteria on Day 43. Participants were followed weekly in the Open-label Period until the Facial Wrinkle Scale (FWS) grades assessed by both investigator and participant returned to moderate or severe (investigator and participant grades did not need to match) before being discontinued from the study after completing either the Early Exit or Study Exit Visit. | 0 | None | 0 | 17 | 0 | 17 | View |
| AGN-151586/AGN-151586 | Participants received AGN-151586 during the Double-blind Period and met all the retreatment criteria on Day 43. An additional open-label treatment with AGN-151586 was administered on Day 43. Participants were followed for approximately 6 weeks (through Day 84). | 0 | None | 1 | 437 | 14 | 437 | View |
| Placebo | Participants received 5 intramuscular injections of placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participants may have also received 1 open-label treatment of AGN-151586 on Day 43. | 0 | None | 1 | 156 | 9 | 156 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| INVASIVE DUCTAL BREAST CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |