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 |
|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 | Eligible subjects received two doses of s.c. Clexane over 2 Treatment Periods (1 dose/period). Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until 36 hours (h) post-dose (evening of Day 2). Study drug was administered on the morning of Day 1 following an overnight fast. There were at least 7 days between each dose administration. In period 1, one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection. | 0 | None | 0 | 14 | 4 | 14 | View |
| Treatment Period 2 | Eligible subjects received two doses of s.c. Clexane over 2 Treatment Periods (1 dose/period). Each Treatment Period was of 2 days duration, from the afternoon before dosing (Day 0) until 36 hours (h) post-dose (evening of Day 2). Study drug was administered on the morning of Day 1 following an overnight fast. There were at least 7 days between each dose administration. In period 2 one dose of Clexane was administered s.c. into the left or right side of the abdomen (alternating sides with Treatment Period). This dose contained 80 mg enoxaparin sodium (equivalent to 8,000 international units (IU) anti-factor Xa (anti FXa activity) in 0.8 mL of water for injection. | 0 | None | 0 | 14 | 2 | 14 | View |