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 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
NCT ID:
NCT03580356
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.
Study:
NCT03580356
Study Brief:
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ligelizumab 72mg (Adults) | Ligelizumab 72mg (Adults): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w | 0 | None | 3 | 304 | 177 | 304 | View |
| Ligelizumab 72mg (Adolescents) | Ligelizumab 72mg (Adolescents): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w | 0 | None | 0 | 16 | 7 | 16 | View |
| Ligelizumab 72mg (Adults+Adolescents) | Ligelizumab 72mg (Adults+Adolescents): 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w | 0 | None | 3 | 320 | 184 | 320 | View |
| Ligelizumab 120 mg (Adults) | Ligelizumab 120 mg (Adults): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w | 1 | None | 3 | 306 | 182 | 306 | View |
| Ligelizumab 120 mg (Adolescents) | Ligelizumab 120 mg (Adolescents): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w | 0 | None | 0 | 19 | 10 | 19 | View |
| Ligelizumab 120 mg (Adults+Adolescents) | Ligelizumab 120 mg (Adults+Adolescents): 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w | 1 | None | 3 | 325 | 192 | 325 | View |
| Omalizumab 300mg (Adults) | Omalizumab 300mg (Adults): 2 injections of 1.2 mL omalizumab q4w | 0 | None | 2 | 307 | 165 | 307 | View |
| Omalizumab 300mg (Adolescents) | Omalizumab 300mg (Adolescents): 2 injections of 1.2 mL omalizumab q4w | 0 | None | 0 | 14 | 10 | 14 | View |
| Omalizumab 300mg (Adults+Adolescents) | Omalizumab 300mg (Adults+Adolescents): 2 injections of 1.2 mL omalizumab q4w | 0 | None | 2 | 321 | 175 | 321 | View |
| Placebo Only (Adults) | Placebo only (Adults): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented | 0 | None | 1 | 103 | 40 | 103 | View |
| Placebo Only (Adolescents) | Placebo only (Adolescents): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented | 0 | None | 0 | 6 | 1 | 6 | View |
| Placebo Only (Adults+Adolescents) | Placebo only (Adults+Adolescents): Safety events between Wk 0- 24 (until participants received Ligelizumab 120 mg) are presented | 0 | None | 1 | 109 | 41 | 109 | View |
| Transitioned to Ligelizumab 120mg (Adults) | Placebo Adults patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented. | 0 | None | 0 | 90 | 37 | 90 | View |
| Transitioned to Ligelizumab 120mg (Adolescents) | Placebo Adolescents patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented. | 0 | None | 0 | 6 | 2 | 6 | View |
| Transitioned to Ligelizumab 120mg (Adults+Adolescents) | Placebo Adults+Adolescents patients who transitioned to ligelizumab 120mg; 1 injection of 1.0mL of ligelizumab, 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48. At week 24 participants received active drug. Safety events from week 24 to end of study are presented. | 0 | None | 0 | 96 | 39 | 96 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Angioedema | 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 |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.0) | View |
| Gastrooesophageal reflux disease | 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 |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Injection site urticaria | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Influenza | 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 |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.0) | View |
| Tonsillitis | 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 |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| SARS-CoV-2 test negative | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.0) | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (25.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Chronic spontaneous urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.0) | View |
| Eczema | 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 |