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 @ 4:52 PM
Ignite Modification Date:
2025-12-25 @ 2:35 PM
NCT ID:
NCT04250350
Description:
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Frequency Threshold:
0
Time Frame:
Baseline up to Week 52
Study:
NCT04250350
Study Brief:
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants 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 |
|---|---|---|---|---|---|---|---|---|
| Lebrikizumab 250mg | Participants received two SC injections of 250 mg Lebrikizumab at Baseline and Week 2 followed by a single injection Q2W from Week 4 up to (but not including) Week 52. | 1 | None | 5 | 206 | 133 | 206 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.0 | View |
| Multiple injuries | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Testicular torsion | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Vaccination site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| Hypertransaminasaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |
| Food allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |
| Multiple allergies | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Conjunctivitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Eczema herpeticum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Herpes dermatitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Herpes ophthalmic | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pelvic inflammatory disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Pharyngitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Staphylococcal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Tinea versicolour | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| Animal bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Nail injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Post procedural complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Procedural dizziness | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Vaccination complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Mean cell haemoglobin concentration decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Neutrophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| Gluten sensitivity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| Vitamin d deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| Cutaneous t-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Lipoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Attention deficit hyperactivity disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Persistent depressive disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Social anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| Heavy menstrual bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| Menstruation irregular | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| Polymenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| Adenoidal hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Catarrh | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Tonsillar hypertrophy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Alopecia areata | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Dandruff | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Ingrowing nail | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Milia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Perioral dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Seborrhoeic dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Skin exfoliation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Haemolytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| Sinus arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| Thyroglossal cyst | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 25.0 | View |
| Type v hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 25.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.0 | View |
| Atopic keratoconjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Conjunctivitis allergic | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Episcleritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Eye irritation | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Eyelids pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Ocular hyperaemia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Angular cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |