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 |
|---|---|---|---|---|---|---|---|---|
| Granulated Sugar Arm | Participants will start taking the granulated sugar three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the Fermented Papaya Preparation (FPP) in the same way as the granulated sugar was taken. Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks. Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks. Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22. Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22. | 0 | None | 2 | 30 | 5 | 30 | View |
| Fermented Papaya Preparation Arm | Participants will start taking the Fermented Papaya Preparation (FPP) three times per day, for 8 week. Then there will be a 6 week washout period. After the washout period the participants will start taking the granulated sugar in the same way as the FPP was taken. Fermented Papaya Preparation: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks. Granulated Sugar: This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks. Magnetic Resonance Spectroscopy: MRS will be performed during weeks 0, 8, 14, and 22. Magnetic resonance imaging: MRS will be performed during weeks 0, 8, 14, and 22. | 0 | None | 0 | 30 | 4 | 30 | View |
| Washout Period | This is the 6 week period between the FPP and Placebo arms. | 0 | None | 1 | 30 | 2 | 30 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headaches | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Influenza | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Swelling in legs and feet | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Stage 3 Kidney Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Dazedness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Anger/Hostility | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Stomach ache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Common cold | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Broken foot | SYSTEMATIC_ASSESSMENT | General disorders | None | View |