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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT02963506
Description:
At Week 12, placebo, BKZ 16 mg and BKZ 64 mg subjects were re-randomized to either BKZ 160 mg or BKZ 320 mg. Subjects randomized to BKZ 160 mg group or BKZ 320 mg at Baseline were not re-randomized at Week 12 and remained on their original treatment. The Safety Set is based on actual treatment, other populations are based on planned treatment.
Frequency Threshold:
5
Time Frame:
Treatment-emergent adverse events (TEAEs) were collected from Baseline until the Safety Follow-Up Visit (up to Week 73)
Study:
NCT02963506
Study Brief:
A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis
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 (SS) - up to Wk 12 | This arm consisted of all participants who received placebo at any time in the study (up to Week 12). Participants formed the Safety Set (SS). | 0 | None | 2 | 60 | 2 | 60 | View |
| BKZ 16 mg (SS) - up to Wk 12 | This arm consisted of all participants who received bimekizumab (BKZ) 16 milligrams (mg) every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. | 0 | None | 0 | 61 | 2 | 61 | View |
| BKZ 64 mg (SS) - up to Wk 12 | This arm consisted of all participants who received bimekizumab (BKZ) 64 mg every 4 weeks (Q4W) at any time in the study (up to Week 12). Participants formed the SS. | 0 | None | 2 | 58 | 4 | 58 | View |
| BKZ 160 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 160 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. | 1 | None | 5 | 149 | 42 | 149 | View |
| BKZ 320 mg (SS) - up to Wk 73 | This arm consisted of all participants who received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) at any time in the study (up to Week 73). Participants formed the SS. | 0 | None | 6 | 150 | 56 | 150 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic 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 |
| Inner ear disorder | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA19.0 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Crohn's disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Intestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Bursitis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Abscess limb | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Pilonidal cyst | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Colon adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Oral fungal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |