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 |
|---|---|---|---|---|---|---|---|---|
| ACAM2000 Dose 3 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0 | None | None | 0 | 101 | 98 | 101 | View |
| ACAM2000 Dose 1 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0 | None | None | 1 | 51 | 51 | 51 | View |
| ACAM2000 Dose 2 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0 | None | None | 1 | 101 | 99 | 101 | View |
| ACAM2000 Dose 4 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0 | None | None | 1 | 51 | 51 | 51 | View |
| Dryvax® Vaccine | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0 | None | None | 0 | 49 | 49 | 49 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pregnancy Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymph Node Pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 6.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 6.0 | View |
| Diarrhea Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| Vomiting Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| Injection Site Pruritus | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection Site Erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Feeling Hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Rigors | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Injection Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | View |
| Headache Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 6.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 6.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 6.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | View |
| Rash Not Otherwise Specified | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 6.0 | View |