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 @ 2:58 PM
Ignite Modification Date:
2025-12-25 @ 1:23 PM
NCT ID:
NCT02319759
Description:
The safety analysis set included all participants who received at least 1 (partial or complete) dose of study agent and were analyzed based on the actual treatment received.
Frequency Threshold:
5
Time Frame:
Up to Week 56
Study:
NCT02319759
Study Brief:
Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
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 (Week 0 to Week 24) | Participants received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20. Data through Week 24 prior to receiving guselkumab or through Week 16 prior to receiving ustekinumab (for participants who early escaped at week 16) were included. | 0 | None | 1 | 49 | 7 | 49 | View |
| Placebo to Guselkumab (Week 24 to Week 56) | Participants who received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and 20 received guselkumab 100 mg subcutaneous injections at Week 24, 28, 36 and 44. Data from the first administration of guselkumab (Week 24) through Week 56 (final follow-up) were included. | 0 | None | 0 | 29 | 3 | 29 | View |
| Guselkumab (Week 0 to Week 56) | Participants received guselkumab 100 mg subcutaneous injections at Weeks 0, 4, 12, 20, 28, 36 and 44, and matched placebo at Week 24. Data from Week 0 through Week 56 (final follow-up) or through Week 16 prior to receiving ustekinumab (for participants who early escaped at week 16) were included. | 0 | None | 6 | 100 | 24 | 100 | View |
| Placebo to Ustekinumab (EE: Week 16 to Week 56) | Participants who received placebo matched to guselkumab subcutaneous injections at Weeks 0, 4, 12 and were qualified to early escape (EE) at Week 16 received open-label ustekinumab subcutaneous injections at Weeks 16, 20, 32 and 44 at the approved dosage for PsA in the particular country of the study. Data from the first administration of ustekinumab (Week 16) through Week 56 (final follow-up) were included. | 0 | None | 0 | 17 | 8 | 17 | View |
| Guselkumab to Ustekinumab (EE:Week 16 to Week 56) | Participants who received guselkumab subcutaneous injections at Weeks 0, 4, 12 and were qualified to early escape (EE) at Week 16 received open-label ustekinumab subcutaneous injections at Weeks 16, 20, 32 and 44 at the approved dosage for PsA in the particular country of the study. Data from the first administration of ustekinumab (Week 16) through Week 56 (final follow-up) were included. | 0 | None | 0 | 10 | 3 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Joint Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Radius Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 19.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Ulcerative Keratitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 19.1 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 19.1 | View |
| Pupils Unequal | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 19.1 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 19.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 19.1 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Weight Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 19.1 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | View |
| Depressive Symptom | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 19.1 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | View |
| Upper Respiratory Tract Inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | View |