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 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
NCT ID:
NCT03370133
Description:
Treatment-emergent AEs were defined as those AEs that had a start date on or following the first dose of study treatment through the final dose of study treatment + 140 days (covering the 20-week Safety Follow-Up \[SFU\] Period). Deaths in Any bimekizumab 320 mg Q4W arm occurred in the Initial Period (1 in placebo/ 1 in bimekizumab 320 mg Q4W).
Frequency Threshold:
5
Time Frame:
Treatment-emergent AEs were collected from Baseline to Safety Follow Up (up to Week 68)
Study:
NCT03370133
Study Brief:
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bimekizumab 320 mg Q4W Initial Period (SS) | During the 16-week Initial Treatment Period participants received bimekizumab 320 mg Q4W. Participants formed the SS. | 1 | None | 5 | 321 | 87 | 321 | View |
| Ustekinumab Initial Period (SS) | During the 16-week Initial Treatment Period participants received ustekinumab 45 mg or 90 mg (depending on participants weight). Participants formed the SS. | 1 | None | 5 | 163 | 37 | 163 | View |
| Any Bimekizumab 320 mg Q4W (AMS) | This arm consisted of all participants who received bimekizumab 320 mg Q4W at any time in the study (up to Week 52). It also includes the participants that switched from placebo to bimekizumab 320 mg Q4W after the 16-week Initial Treatment Period. Participants formed the SS. | 2 | None | 24 | 395 | 192 | 395 | View |
| Any Ustekinumab (AMS) | This arm consisted of all participants who received ustekinumab 45 mg or 90 mg (depending on participants weight) at any time in the study (up to Week 52). Participants formed the SS. | 1 | None | 13 | 163 | 73 | 163 | View |
| Placebo Initial Period (SS) | During the 16-week Initial Treatment Period participants received placebo. Participants formed the Safety Set (SS). | 1 | None | 2 | 83 | 17 | 83 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Subglottic laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Upper limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA19.0 | View |
| Osteochondrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Spinal column stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Oesophageal adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | View |
| Gastric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Intracranial aneurysm | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA19.0 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA19.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA19.0 | View |
| Macular hole | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA19.0 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA19.0 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Oesophageal candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Mastoiditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Infective tenosynovitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Necrotising fasciitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Heart injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Tendon injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Toxicity to various agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Tibia fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA19.0 | View |
| False positive tuberculosis test | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA19.0 | View |
| Facet joint syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Thyroid adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | View |
| Brain injury | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Vocal cord paresis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Haemorrhage in pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA19.0 | View |
| Alcoholism | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA19.0 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA19.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.0 | View |
| Metabolic surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA19.0 | View |