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 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
NCT ID:
NCT00245960
Description:
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00245960
Study Brief:
Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Etanercept BIW/QW | Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. | None | None | 15 | None | 213 | None | View |
| Etanercept QW/QW | Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24. | None | None | 11 | None | 190 | None | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Accidental injury | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cerebral ischemia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Myocardial ischemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Gastrointestinal hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Large intestine perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Melena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Stomach ulcer hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Abnormal gait | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Chronic obstructive airways disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Skin carcinoma | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Breast carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Kidney pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Local reaction to procedure | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Metabolic and nutritional general disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Nervous general disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Upper respiratory infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Injection site | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cardiovascular general disorders | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Digestive general disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Skin and appendages general disorders | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |