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 |
|---|---|---|---|---|---|---|---|---|
| OE U.K. Tablet Then U.K. Tablet | Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally | None | None | 0 | 23 | 13 | 45 | View |
| U.K. Tablet Then OE U.K. Tablet | U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally | None | None | 1 | 22 | 6 | 44 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Aborted Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 7.1 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 7.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 7.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 7.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 7.1 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 7.1 | View |
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 7.1 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 7.1 | View |
| Menorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 7.1 | View |
| Pharyngolaryngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 7.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 7.1 | View |
| Haematocrit Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 7.1 | View |
| Haemoglobin Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 7.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 7.1 | View |
| Sinus Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 7.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 7.1 | View |