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
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
NCT ID:
NCT03736967
Description:
None
Frequency Threshold:
5
Time Frame:
All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (Week 36) regardless of seriousness or relationship to investigational product (IP).
Study:
NCT03736967
Study Brief:
Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo Q2W | Participants received 2 subcutaneous (SC) injections of placebo matched to REGN3500 and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of placebo matched to REGN3500 and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14. | 0 | None | 1 | 50 | 17 | 50 | View |
| Dupilumab 300 mg Q2W | Participants received 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) and 2 SC injections of placebo matched to REGN3500 on Day 1 and then 1 SC injection of Dupilumab at a dose 300 mg and 2 SC injections of placebo matched to REGN3500 Q2W up to Week 14. | 0 | None | 2 | 51 | 25 | 51 | View |
| R3500 300 mg and Dupilumab 300 mg Q2W | Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of Dupilumab at a dose of 300 mg (600 mg loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg and 1 SC injection of Dupilumab at a dose of 300 mg Q2W up to Week 14. | 1 | None | 1 | 52 | 20 | 52 | View |
| R3500 300 mg Q2W | Participants received 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 2 SC injections of placebo matched to Dupilumab (loading dose) on Day 1 and then 2 SC injections of REGN3500 at a dose of 150 mg (300 mg loading dose) and 1 SC injection of placebo matched to Dupilumab Q2W up to Week 14. | 0 | None | 1 | 52 | 15 | 52 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23) | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23) | View |
| Goodpasture's syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (23) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23) | View |
| Intracranial aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23) | View |
| Ruptured cerebral aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23) | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23) | View |
| Conjunctivitis allergic | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23) | View |