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 |
|---|---|---|---|---|---|---|---|---|
| Erlotinib | Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files. | None | None | 14 | 291 | 134 | 291 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.1 | View |
| Aphthous ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | View |
| Diffuse alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.1 | View |
| Feeling cold | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.1 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.1 | View |
| Hypogeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.1 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.1 | View |