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 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
NCT ID:
NCT01100034
Description:
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both a serious and non-serious event during study.
Frequency Threshold:
0
Time Frame:
Baseline up to 28 days after last dose of study drug (up to 61 months)
Study:
NCT01100034
Study Brief:
Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric 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 |
|---|---|---|---|---|---|---|---|---|
| Etanercept | Participants who were diagnosed with plaque psoriasis and on routine treatment of etanercept as per standard clinical practice were enrolled in this study and observed for approximately 5 years. Participants were observed for every 3 months during the first 2 years of the study and every 6 months thereafter for 3 years. | 0 | None | 11 | 72 | 44 | 72 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v14.0 | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v14.0 | View |
| Hepatic steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v14.0 | View |
| Chronic tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Cholesteatoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v14.0 | View |
| Anorexia nervosa | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v14.0 | View |
| Erythema nodosum | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v14.0 | View |
| Erythrodermic psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v14.0 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v14.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v14.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v14.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v14.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v14.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v14.0 | View |
| Irritable bowel syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v14.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v14.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v14.0 | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v14.0 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v14.0 | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v14.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v14.0 | View |
| No adverse event | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v14.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v14.0 | View |
| Acute tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Eczema infected | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Enterovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Gastrointestinal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Hordeolum | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Respiratory tract infection viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Scarlet fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Streptococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v14.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v14.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v14.0 | View |
| Muscle rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v14.0 | View |
| Skeletal injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v14.0 | View |
| Sunburn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v14.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v14.0 | View |
| Eosinophil count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v14.0 | View |
| Liver function test abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v14.0 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v14.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | View |
| Exostosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | View |
| Skin papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v14.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v14.0 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v14.0 | View |
| Transient global amnesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v14.0 | View |
| Pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v14.0 | View |
| Somatoform disorder neurologic | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v14.0 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v14.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v14.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v14.0 | View |
| Psoriasis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v14.0 | View |
| Vitiligo | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v14.0 | View |
| Venous thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v14.0 | View |