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:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
NCT ID:
NCT04071405
Description:
An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event. Safety population defined as records from all participants collected into the study were included. Events were recorded from participants' clinical practice hospital documents.
Frequency Threshold:
0
Time Frame:
From first dose of Xeljanz until 52 weeks
Study:
NCT04071405
Study Brief:
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tofacitinib | Participants with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to basic treatments or biological agents and received tofacitinib as part of routine practice at Korean health care centers were observed. | 0 | None | 8 | 107 | 41 | 107 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Pouchitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Cytomegalovirus colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v25.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Gastritis erosive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Oral pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Loss of therapeutic response | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Clostridium difficile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Cytomegalovirus colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Spinal column injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Transaminases increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Vitamin D decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.0 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.0 | View |
| Increased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v25.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Essential thrombocythaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | View |
| Uterine leiomyoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Amenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.0 | View |
| Atrophic vulvovaginitis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.0 | View |
| Cervical polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.0 | View |
| Cervix inflammation | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.0 | View |
| Endometriosis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.0 | View |
| Menstruation irregular | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Onycholysis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Skin exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Skin hyperpigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |