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 |
|---|---|---|---|---|---|---|---|---|
| Fecal Microbiota_Fresh | Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was used within 2 hours of preparation (Fresh). Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. | 0 | None | 0 | 26 | 2 | 26 | View |
| Fecal Microbiota_Frozen | Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was kept at -80 C freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen). Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. | 1 | None | 1 | 27 | 2 | 27 | View |
| Fecal Microbiota_Lyophilized | Donor stool (greater than 150 grams) was collected \<4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day. Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. | 0 | None | 1 | 24 | 6 | 24 | View |