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 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
NCT ID:
NCT03346434
Description:
None
Frequency Threshold:
5
Time Frame:
From day of first treatment up to Week 28 (end of study)
Study:
NCT03346434
Study Brief:
Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | 0 | None | 0 | 10 | 7 | 10 | View |
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | Participants received a single SC injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | 0 | None | 1 | 10 | 3 | 10 | View |
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | Participants received a single SC injection of dupilumab at a dose of 6 mg/kg at Day 1. At week 4, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | 0 | None | 0 | 10 | 2 | 10 | View |
| Part B: Placebo + TCS | Participants received SC injection of placebo matched to dupilumab Q4W for 16 weeks along with low potency TCS applied once daily to areas with active lesions. At week 16, participants could roll over into an OLE study (R668-AD-1434/ NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, end of study \[EOS\] period). | 0 | None | 4 | 78 | 45 | 78 | View |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | Participants received a single subcutaneous (SC) injection of dupilumab at a dose of 3 mg/kg at Day 1. At week 4, participants could roll over into an open-label extension (OLE) study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 4 weeks for safety. | 0 | None | 1 | 10 | 7 | 10 | View |
| Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | Participants with baseline weight of ≥ 5 to \< 15 kilogram (kg) received SC injections of 200 mg or participants with baseline weight ≥ 15 to \< 30 kg received SC injections of 300 mg of dupilumab at Day 1 and Q4W from week 4 to week 12. Participants applied low potency TCS once daily to areas with active lesions for 16 weeks. At week 16, participants could roll over into an OLE study (R668-AD-1434/NCT02612454), if considered eligible. Participants who did not enter the OLE study were followed for up to an additional 12 weeks for safety (Week 28, EOS period). | 0 | None | 0 | 83 | 29 | 83 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 (Part A) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.1 (Part B) | View |
| Cellulitis staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 (Part B) | View |
| Dermatitis infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 (Part B) | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 (Part B) | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.1 (Part B) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1; 23.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1; 23.1 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1; 23.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 (Part A) | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1; 23.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1; 23.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 (Part B) | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 (Part A) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1; 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1; 23.1 | View |
| Teething | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 (Part A) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 (Part B) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1; 23.1 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1; 23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1; 23.1 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 (Part A) | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 (Part A) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 (Part A) | View |