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 |
|---|---|---|---|---|---|---|---|---|
| Dupilumab+Open Label Extension and Follow-Up | Participants received a loading dose of two 300 mg subcutaneous injections on Day 0 followed by 300 mg subcutaneous injections every two weeks (Days 14 and 28). Participants started a 10 week OLE on Day 42, beginning with a loading dose of two subcutaneously administered injections (one 300 mg dose of dupilumab and one dose of placebo, in order to protect prior masking/blind). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182. | 0 | None | 1 | 46 | 27 | 46 | View |
| Placebo+Open Label Extension and Follow-Up | Placebo contained the identical formulation as the dupilumab formulation without the active monoclonal antibody and was given by exactly the same route and schedule through Day 28. Participants started a 10 week OLE on Day 42, beginning with a loading dose of dupilumab (two 300 mg subcutaneous injections \[total of 600 mg\]-protection of prior masking/blind maintained). Participants then maintained a regimen of 300 mg of dupilumab by subcutaneous injection every two weeks through Day 98. The participants then entered a follow-up period until Day 182. | 0 | None | 0 | 26 | 17 | 26 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Conjunctivitis allergic | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.0 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.0 | View |