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:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
NCT ID:
NCT02277769
Description:
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study \[Week 28\]). Analysis was performed on safety population.
Frequency Threshold:
5
Time Frame:
All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product.
Study:
NCT02277769
Study Brief:
Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to 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 | Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks) | 0 | None | 16 | 234 | 109 | 234 | View |
| Dupilumab 300 mg q2w | Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks). | 3 | None | 6 | 236 | 84 | 236 | View |
| Dupilumab 300 mg qw | Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks). | 1 | None | 9 | 237 | 90 | 237 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | meddra (18.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra (18.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | meddra (18.0) | View |
| Angle closure glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | meddra (18.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra (18.0) | View |
| Colonic pseudo-obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | meddra (18.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Endocarditis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Septic embolus | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | meddra (18.0) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra (18.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra (18.0) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra (18.0) | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | meddra (18.0) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra (18.0) | View |
| Tetany | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | meddra (18.0) | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | meddra (18.0) | View |
| Hodgkin's disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (18.0) | View |
| Malignant melanoma in situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (18.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra (18.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra (18.0) | View |
| Hypoxic-Ischaemic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra (18.0) | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | meddra (18.0) | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | meddra (18.0) | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra (18.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra (18.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra (18.0) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra (18.0) | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra (18.0) | View |
| Schizophrenia, paranoid type | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra (18.0) | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra (18.0) | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | meddra (18.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | meddra (18.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra (18.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | meddra (18.0) | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | meddra (18.0) | View |
| Dermatitis exfoliative | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 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 |
| Nasopharyngitis | 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 |