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 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 1:59 PM
NCT ID:
NCT03410992
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 Period).
Frequency Threshold:
5
Time Frame:
Adverse events were collected from Baseline (Week 0) until Safety Follow-Up Visit (up to 80 weeks duration)
Study:
NCT03410992
Study Brief:
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab 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 |
|---|---|---|---|---|---|---|---|---|
| Placebo (SS) | Participants received placebo for 16 weeks. Participants who achieved a Psoriasis Area Severity Index (PASI) 90 response criteria proceeded with placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Safety Set (SS). | 0 | None | 2 | 86 | 15 | 86 | View |
| Bimekizumab 320 mg Q4W (SS) | Participants received bimekizumab 320 mg Q4W for 16 weeks. Participants who achieved a PASI90 response criteria were re-randomized to either receive bimekizumab 320 mg Q4W or bimekizumab 320 mg Q8W or placebo until Week 56. Participants who did not achieve a PASI90 response criteria at Week 16 or who relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the SS. | 0 | None | 6 | 349 | 66 | 349 | View |
| Placebo/Placebo (WK16ResS) | Participants in this arm were randomized to placebo during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive placebo during the Randomized-Withdrawal Period. Participants formed the Week 16 Responder Set (WK16ResS). | 0 | None | 0 | 1 | 1 | 1 | View |
| Bimekizumab 320 mg Q4W/Placebo (WK16ResS) | Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants formed the WK16ResS. | 0 | None | 4 | 105 | 34 | 105 | View |
| Bimekizumab 320 mg Q4W/Q8W (WK16ResS) | Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding. | 0 | None | 3 | 100 | 40 | 100 | View |
| Bimekizumab 320 mg Q4W/Q4W (WK16ResS) | Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants formed the WK16ResS. | 0 | None | 5 | 106 | 34 | 106 | View |
| Placebo Escape (ESS) | Participants in this arm were randomized to placebo during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the Escape Study Participant Set (ESS). | 0 | None | 1 | 81 | 8 | 81 | View |
| Bimekizumab 320 mg Q4W Escape (ESS) | Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, did not achieve a PASI90 response at Week 16, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. | 0 | None | 0 | 23 | 5 | 23 | View |
| Bimekizumab 320 mg Q4W/ Placebo Escape (ESS) | Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive placebo during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. | 0 | None | 0 | 67 | 11 | 67 | View |
| Bimekizumab 320 mg Q4W/Q8W Escape (ESS) | Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and were re-randomized to receive bimekizumab 320 mg Q8W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. Participants receiving 320 mg Q8W received placebo at pre-specified time points to maintain the blinding. | 0 | None | 0 | 4 | 3 | 4 | View |
| Bimekizumab 320 mg Q4W/Q4W Escape (ESS) | Participants in this arm were randomized to bimekizumab 320 mg Q4W during the Initial Treatment Period, achieved a PASI90 response at Week 16 and continued to receive bimekizumab 320 mg Q4W during the Randomized-Withdrawal Period. Participants relapsed at Week 20 or later, entered the escape arm and received open-label bimekizumab 320 mg Q4W for 12 weeks. Participants formed the ESS. | 0 | None | 0 | 7 | 4 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Otitis media chronic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Psoriatic arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Ovarian adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | View |
| Pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA19.0 | View |
| Erythrodermic psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.0 | View |
| Ischaemic cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA19.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA19.0 | View |
| Duodenal ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Type 2 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA19.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA19.0 | View |
| Mitral valve prolapse | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA19.0 | View |
| Retinal detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA19.0 | View |
| Gastrointestinal inflammation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Diverticular perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA19.0 | View |
| Enterovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA19.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA19.0 | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | 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 |
| Tinea pedis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Impetigo | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Body tinea | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Tinea capitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA19.0 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.0 | View |
| Seborrhoeic dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.0 | View |
| Rash papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA19.0 | View |