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 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
NCT ID:
NCT02203032
Description:
Safety analysis included all participants who were enrolled at Week 0 and received at least 1 dose of study agent administration.
Frequency Threshold:
5
Time Frame:
Up to Week 60
Study:
NCT02203032
Study Brief:
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ustekinumab (Open Label Run-in) | All participants received ustekinumab 45 milligram (mg) (participants weighing less than or equal to \[\<=\]100 kilogram \[kg\]) or 90 mg (participants weighing \>100 kg) at Weeks 0 and 4. At Week 16, participants with IGA \>=2 were randomized to either switch to guselkumab 100 mg at Weeks 16 and 20 and then every 8 weeks thereafter or continue on ustekinumab every 12 weeks (q12w); participants with an IGA=0 or 1 were to continue to receive open-label ustekinumab q12w. | None | None | 11 | 871 | 80 | 871 | View |
| 100 mg Guselkumab (Randomized) | Participants from open label run-in phase with an investigator global assessment (IGA) greater than or equal to (\>=) 2 at Week 16 who were randomized to guselkumab, received guselkumab 100 mg at Weeks 16, 20, 28, 36, and 44 and placebo for ustekinumab at Weeks 16, 28, and 40. | None | None | 9 | 135 | 37 | 135 | View |
| Ustekinumab (Randomized) | Participants from open label run-in phase with an IGA \>=2 at Week 16 who were randomized to ustekinumab, continued to receive ustekinumab, according to their baseline (Week 0) weight, at Weeks 16, 28, and 40, and placebo for guselkumab at Weeks 16, 20, 28, 36, and 44. | None | None | 6 | 133 | 33 | 133 | View |
| Ustekinumab (Nonrandomized Open Label Continuation) | Participants from open label run-in phase with an IGA=0 or 1 at Week 16 received ustekinumab 45 mg or 90 mg (according to their baseline weight \[Week 0\]) at Weeks 16, 28, and 40. | None | None | 20 | 585 | 60 | 585 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.1 | View |
| Angina Unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.1 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.1 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.1 | View |
| Sinus Node Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 18.1 | View |
| Blindness | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.1 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.1 | View |
| Retinal Artery Embolism | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.1 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.1 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.1 | View |
| Bile Duct Stenosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 18.1 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 18.1 | View |
| Anal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Paraspinal Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Pneumonia Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Alcohol Poisoning | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.1 | View |
| Scapula Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.1 | View |
| Tibia Fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.1 | View |
| Toxicity to Various Agents | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 18.1 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | View |
| Foot Deformity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 18.1 | View |
| Bile Duct Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | View |
| Pancreatic Carcinoma Metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | View |
| Transitional Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.1 | View |
| Ectopic Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 18.1 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.1 | View |
| Large Intestinal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 18.1 | View |
| Chest Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 18.1 | View |
| Arthritis Bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Epididymitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Salpingitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 18.1 | View |
| Squamous Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 18.1 | View |
| Abortion Spontaneous | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA Version 18.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 18.1 | View |
| Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.1 | View |
| Type 2 Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 18.1 | View |
| Retinal Detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 18.1 | View |