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 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
NCT ID:
NCT02525094
Description:
AEs were reported for As-treated population, which included all participants who received any study drug. Participants who received at least one dose of MEDI9929, regardless of randomized treatment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group
Frequency Threshold:
1
Time Frame:
From treatment administration (Day1) to 22 weeks
Study:
NCT02525094
Study Brief:
Phase 2a Study to Evaluate the Efficacy and Safety of MEDI9929 in Adults With 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 received 6 subcutaneous doses of placebo every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22. | None | None | 3 | 55 | 33 | 55 | View |
| MEDI9929 280 mg | Participants received 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks (with the last dose at Week 10) and were followed up till Week 22. Additionally, the participants received maintenance therapy of Class 3 topical corticosteroids (TCS) cream or ointment for lesional skin from the start of the run-in period (Visit 2, Week -2) to Week 22. | None | None | 2 | 56 | 29 | 56 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Infected dermal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Food allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 19.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |