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 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
NCT ID:
NCT02395133
Description:
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time from the first dose of study drug up to the end of study \[Week 36\]). The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Note: One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in the SAF
Frequency Threshold:
5
Time Frame:
All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Study:
NCT02395133
Study Brief:
A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)
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 QW | Subcutaneous injection of Placebo (for Dupilumab) was administered weekly (QW) from Week 1 (Day 1) to Week 36. | 0 | None | 1 | 82 | 55 | 82 | View |
| Dupilumab 300 mg Q8W | Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every eight week (Q8W) from Week 1 to Week 36. | 0 | None | 3 | 84 | 43 | 84 | View |
| Dupilumab 300 mg Q4W | Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every four week (Q4W) from Week 1 to Week 36. | 1 | None | 4 | 87 | 47 | 87 | View |
| Dupilumab 300 mg Q2W/QW | Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) once every week (QW) or twice a week (Q2W) from Week 1 to Week 36. | 0 | None | 6 | 167 | 72 | 167 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra (18.0) | View |
| Tachycardia induced cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra (18.0) | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | meddra (18.0) | View |
| Gun shot wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra (18.0) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra (18.0) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (18.0) | View |
| Glioblastoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (18.0) | View |
| Biochemical pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | meddra (18.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra (18.0) | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra (18.0) | View |
| Abortion induced | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | meddra (18.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra (18.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | meddra (18.0) | View |
| Ligament Rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Wound Dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Muscle injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra (18.0) | View |
| Open fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra (18.0) | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (18.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | meddra (18.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra (18.0) | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra (18.0) | View |