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 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT02905006
Description:
It was pre-specified to report adverse events (AE) that have a start date on or following the first administration of study treatment. TEAEs counts are for each study period: Treatment Period (Wk1-12) for all participants who received at least 1 study treatment and Post-Treatment Period for participants who either enrolled in an extension study (PS0011) or those who entered a 20-week Safety Follow-Up Period.
Frequency Threshold:
5
Time Frame:
Treatment-emergent adverse events (TEAEs) were collected from Baseline (Week 0) to End of Safety Follow-up (up to Week 28)
Study:
NCT02905006
Study Brief:
Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With 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) Treatment Period | During the Treatment Period participants randomized to the placebo group, received a combination of several injections of placebo, subcutaneously every 4 weeks (Q4W). Participants formed the Safety Set (SS). | 0 | None | 1 | 42 | 8 | 42 | View |
| Bimekizumab 64 mg Q4W (SS) Treatment Period | During the Treatment Period participants were randomized to receive subcutaneous injections of 64 mg bimekizumab Q4W. Participants formed the SS. | 0 | None | 0 | 39 | 16 | 39 | View |
| Bimekizumab 160 mg Q4W (SS) Treatment Period | During the Treatment Period participants were randomized to receive subcutaneous injections of 160 mg bimekizumab Q4W. Participants formed the SS. | 0 | None | 0 | 43 | 12 | 43 | View |
| Bimekizumab 160 mg w/ LD Q4W (SS) Treatment Period | During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W. Participants formed the SS. | 0 | None | 0 | 40 | 12 | 40 | View |
| Bimekizumab 320 mg Q4W (SS) Treatment Period | During the Treatment Period participants were randomized to receive subcutaneous injections of 320 mg bimekizumab Q4W. Participants formed the SS. | 0 | None | 0 | 43 | 14 | 43 | View |
| Bimekizumab 480 mg Q4W (SS) Treatment Period | During the Treatment Period participants were randomized to receive subcutaneous injections of 480 mg bimekizumab Q4W. Participants formed the SS. | 0 | None | 1 | 43 | 10 | 43 | View |
| Placebo (SS) Post-Treatment Period | At Week 12, participants who were randomized to receive Placebo during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS. | 0 | None | 0 | 42 | 0 | 42 | View |
| Bimekizumab 64 mg Q4W (SS) Post-Treatment Period | At Week 12, participants who were randomized to receive 64 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS. | 0 | None | 1 | 39 | 0 | 39 | View |
| Bimekizumab 160 mg Q4W (SS) Post-Treatment Period | At Week 12, participants who were randomized to receive 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS. | 0 | None | 0 | 43 | 0 | 43 | View |
| Bimekizumab 160 mg w/ LD Q4W (SS) Post-Treatment Period | At Week 12, participants who were randomized to receive 320 mg bimekizumab loading dose at Baseline followed by 160 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS. | 0 | None | 0 | 40 | 0 | 40 | View |
| Bimekizumab 320 mg Q4W (SS) Post-Treatment Period | At Week 12, participants who were randomized to receive 320 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS. | 0 | None | 0 | 43 | 0 | 43 | View |
| Bimekizumab 480 mg Q4W (SS) Post-Treatment Period | At Week 12, participants who were randomized to receive 480 mg bimekizumab Q4W during the Treatment Period and who enrolled in the extension study (PS0011), underwent the Week 12 study assessments and then received their first extension study dose of study treatment. All participants who did not enroll in the extension study had the Week 12 study assessments and entered the Safety Follow-Up (SFU) Period, 20 weeks after the last dose of study medication. Participants did not receive any treatment during the Post-Treatment Period. Participants formed the SS. | 0 | None | 0 | 43 | 0 | 43 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Large intestine polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Meningitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA19.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac 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 |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA19.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA19.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA19.0 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA19.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA19.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA19.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA19.0 | View |