Adverse Events Module

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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 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT04033367
Description: Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
Frequency Threshold: 5
Time Frame: From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Study: NCT04033367
Study Brief: SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DB Period: Placebo Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10. 0 None 1 61 18 61 View
OLE Period: Dupilumab/Dupilumab Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22. 0 None 1 122 24 122 View
DB Period: Dupilumab Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10. 0 None 2 127 26 127 View
OLE Period: Placebo/Dupilumab Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22. 0 None 0 60 17 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Multiple Fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Polyarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Bladder Transitional Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dermatitis Atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View