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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT02585258
Description: At every visit, adjudication of adverse events of special interest (AESI). More details, especially on non-SAE AESI ('other AESI') are reported in the main trial publication (see reference list). Specifically for ClinicalTrials.gov, so outside the statistical analysis and reporting plan, we report: * SAE per specific term, * all non-serious AE reported \>5%. This table includes both AESI and non-AESI.
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT02585258
Study Brief: The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prednisolone prednisolone 5 mg per day Prednisolone: capsules 5 mg / day 3 None 55 224 169 224 View
Placebo placebo capsules once per day Placebo: capsules 1 / day 2 None 46 225 164 225 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
melanoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
pancreas carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
renal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
rectal cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
urothelium transitional cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
carotid atherosclerosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
complex regional pain syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
facial paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
neuralgia, intercostal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
radicular syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
transient ischemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
intracranial hemorrhage, traumatic NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
Vertebrobasilar insufficiency NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Meddra 21.0 View
dementia, neuropsychiatric symptoms NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View
dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View
hyperventilation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View
pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View
pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View
cough, productive NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View
pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View
skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Meddra 21.0 View
total hip replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures Meddra 21.0 View
thyroidectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures Meddra 21.0 View
prostatectomy, transurethral NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures Meddra 21.0 View
circulatory collapse NON_SYSTEMATIC_ASSESSMENT Vascular disorders Meddra 21.0 View
hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders Meddra 21.0 View
hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Meddra 21.0 View
arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Meddra 21.0 View
intravertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Meddra 21.0 View
osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Meddra 21.0 View
lung carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
B-cell lymphoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
basal cell carinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
epenymoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
gastrointestinal stromal tumor NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 21.0 View
contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 21.0 View
spine fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 21.0 View
AV block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 21.0 View
malaise NON_SYSTEMATIC_ASSESSMENT General disorders Meddra 21.0 View
appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
epidydimitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
chesst discomfort/pain NON_SYSTEMATIC_ASSESSMENT General disorders Meddra 21.0 View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders Meddra 21.0 View
abcess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
bursitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
covid-19 pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
fungal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
infectious pleural effusion NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
parainfluenzae infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
gastroenteritis, parasitic NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
salmonellosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
Postoperative abscess Hematoma infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
peritonitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 21.0 View
multiple fractures NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 21.0 View
pelvic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 21.0 View
synovial rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 21.0 View
tendon rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 21.0 View
prostate specific antigen increased NON_SYSTEMATIC_ASSESSMENT Investigations Meddra 21.0 View
weight decrease NON_SYSTEMATIC_ASSESSMENT Investigations Meddra 21.0 View
decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Meddra 21.0 View
dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Meddra 21.0 View
urinary tract obstruction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders Meddra 21.0 View
asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View
myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 21.0 View
myocardial ischemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 21.0 View
atrial fibrillation/flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 21.0 View
cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 21.0 View
aortic valve stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 21.0 View
hyperthyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders Meddra 21.0 View
cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders Meddra 21.0 View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 21.0 View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 21.0 View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 21.0 View
diverticular perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 21.0 View
lower gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 21.0 View
enteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 21.0 View
small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
all nonserious events NON_SYSTEMATIC_ASSESSMENT General disorders Meddra 21.0 View
bronchitis, nasopharyngitis, respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
urinary tract infection, cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
influenza, influenza-like illness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 21.0 View
hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders Meddra 21.0 View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 21.0 View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Meddra 21.0 View