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 |
|---|---|---|---|---|---|---|---|---|
| NT 201 75 U | Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period. | 0 | None | 0 | 61 | 12 | 61 | View |
| NT 201 100 U | Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period. | 0 | None | 1 | 58 | 12 | 58 | View |
| Stage 1 and 2 Pooled: NT 201 20 U | Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period. | 0 | None | 0 | 62 | 13 | 62 | View |
| NT 201 50 U | Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period. | 0 | None | 0 | 60 | 11 | 60 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |