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 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
NCT ID:
NCT03928704
Description:
As pre-specified in SAP, Maintenance Period (MP) included AEs of SFU period for participants who did not enter OLE or discontinued early in MP. Study participants who rolled over to OLE study did not have a SFU visit. TEAEs have been reported for Safety set (SS), MS, AS0010 China Extension Participants SS and AS0010 China Extension Participants MS. Overall Period included all participants who received BKZ 160 mg Q4W during study. Overall Period arm reports repeated TEAEs from DBTP and MP.
Frequency Threshold:
5
Time Frame:
From Baseline (Day 1) until Safety Follow-Up (up to Week 68)
Study:
NCT03928704
Study Brief:
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
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 160 mg Q4W (Week 16 up to Week 52) (Global Population) | At the end of the 16-week Double-Blind Treatment Period, study participants receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52. | 0 | None | 9 | 242 | 94 | 242 | View |
| Placebo (up to Week 16) (Global Population) | Participants received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16. | 0 | None | 1 | 126 | 30 | 126 | View |
| Bimekizumab 160 mg Q4W (up to Week 16) (Global Population) | Participants received bimekizumab 160 mg Q4W subcutaneously until Week 16. | 0 | None | 0 | 128 | 40 | 128 | View |
| Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (Global Population) | Participants who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group. | 0 | None | 9 | 244 | 114 | 244 | View |
| Placebo (up to Week 16) (China Extension Population) | Participants in the China Extension Population received placebo matched to bimekizumab 160 mg Q4W subcutaneously until Week 16. | 0 | None | 0 | 11 | 8 | 11 | View |
| Bimekizumab 160 mg Q4W (up to Week 16) (China Extension Population) | Participants in the China Extension Population received bimekizumab 160 mg Q4W subcutaneously until Week 16. | 0 | None | 0 | 9 | 9 | 9 | View |
| BKZ 160 mg Q4W (Week 16 up to Week 52) (China Extension Population) | At the end of the 16-week Double-Blind Treatment Period, study participants in China Extension Population receiving placebo were re-allocated to bimekizumab treatment at Week 16. Participants from both placebo and bimekizumab arm received bimekizumab 160 mg Q4W subcutaneously from Week 16 until Week 48 during maintenance period. Participants entering the extension study received bimekizumab 160 mg Q4W subcutaneously until Week 52. | 0 | None | 3 | 20 | 13 | 20 | View |
| Overall Period (up to Week 48 + 20 Weeks SFU): Bimekizumab 160 mg Q4W (China Population) | Participants in the China Extension Population who received bimekizumab 160 mg Q4W subcutaneously from Day 1 up to Week 48 and participants who switched from placebo arm at Week 16 to receive bimekizumab 160 mg Q4W subcutaneously up to Week 48 were included in this group. | 0 | None | 3 | 20 | 16 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal adhesions | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Deafness unilateral | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Tonsillitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Clear cell renal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | View |
| Intentional self-injury | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Nasal crusting | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Cervical dysplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.0 | View |
| Abortion induced | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Corona virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Helicobacter infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Tinea pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Tinea versicolour | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Chillblains | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Low density lipoprotein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Liver function test increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Synovial cyst | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Oligomenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Dermal cyst | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 19.0 | View |
| Mouth ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Axial spondyloarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |