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 |
|---|---|---|---|---|---|---|---|---|
| Thyroxin+Folinic Acid Placebo | thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules | 0 | None | 9 | 44 | 0 | 44 | View |
| Thyroxin + Folinic Acid | thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules | 1 | None | 8 | 43 | 0 | 43 | View |
| Thyroxin Placebo+ Folinic Acid | thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules | 0 | None | 8 | 43 | 7 | 43 | View |
| Thyroxin Placebo+ Folinic Acid Placebo | thyroid hormone and folinic acid: thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules | 0 | None | 5 | 44 | 0 | 44 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Respiratory, thoracic and mediastinal disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Injury, poisoning and procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Infections and infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| General disorders and administration site conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.1 | View |
| Metabolism and nutrition disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Surgical and medical procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 20.1 | View |
| Congenital, familial and genetic disorders | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA version 20.1 | View |
| Neoplasm begign, maligant and unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Skin and subcutnaeous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Endocrine disorders | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA version 20.1 | View |
| Neoplasms begnin, malignant and unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | View |
| Nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |