Adverse Events Module

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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 @ 4:46 AM
Ignite Modification Date: 2025-12-26 @ 3:48 AM
NCT ID: NCT01236118
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01236118
Study Brief: A Study of LY2439821 in Rheumatoid 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
30 mg LY2439821 Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. None None 1 6 6 6 View
80 mg LY2439821 Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. None None 0 5 5 5 View
160 mg LY2439821 Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44. None None 2 17 16 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Eczema infected SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Reflux oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Systemic mycosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Tinea pedis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Chillblains SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
Eyelid oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
Colonic polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Dental caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gastritis atrophic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Lip swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
Administration site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
Hepatic function abnormal SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Skeletal injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Eosinophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Hepatitis b dna assay positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Oxygen saturation decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Hand deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Dermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Eczema asteatotic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Hyperkeratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Hyperkeratosis palmaris and plantaris SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
Cardioversion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Percutaneous coronary intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Skin operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View