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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT00596102
Description: group "IC51 Month 6" includes the sub-set of study participants that later on is followed-up until Month 60 (group "IC51 Month 60")
Frequency Threshold: 2
Time Frame: all participants across all treatment groups were followed-up until Month 6; a sub-group of the IC51 treatment arm was followed-up until Month 60
Study: NCT00596102
Study Brief: Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IC51 Month 6 no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 None None 15 2283 78 2283 View
JE-VAX no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 None None 2 338 16 338 View
Placebo no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6 None None 7 637 31 637 View
IC51 Month 60 no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60 None None 14 102 54 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain None Gastrointestinal disorders None View
Abdominal Pain Lower None Gastrointestinal disorders None View
Appendix Disorder None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Appendiceal Abscess None Infections and infestations None View
Appendicitis None Infections and infestations None View
Diverticulitis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Pyelonephritis None Infections and infestations None View
Sepsis None Infections and infestations None View
Head Injury None Injury, poisoning and procedural complications None View
Joint Ligament Rupture None Injury, poisoning and procedural complications None View
Tibia Fructure None Injury, poisoning and procedural complications None View
Rhabdomyolysis None Musculoskeletal and connective tissue disorders None View
Synovial Cyst None Musculoskeletal and connective tissue disorders None View
Adenocarinoma Pancreas None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung Adenocarcinoma Metastatic None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Central Nervous System Inflammation None Nervous system disorders None View
Ectopic Pregnancy None Pregnancy, puerperium and perinatal conditions None View
Nephrolithiasis None Renal and urinary disorders None View
Ovarian Cyst None Reproductive system and breast disorders None View
Mediastinal Mass None Respiratory, thoracic and mediastinal disorders None View
Meniscus Operation None Surgical and medical procedures None View
Tonsillectomy None Surgical and medical procedures None View
Coronary Stenosis None Cardiac disorders None View
Abscess Soft Tissue None Infections and infestations None View
Endometritis None Infections and infestations None View
Tonsillitis None Infections and infestations None View
Lower Limb Fracture None Injury, poisoning and procedural complications None View
Smear Cervix Abnormal None Investigations None View
Shoulder Pain None Musculoskeletal and connective tissue disorders None View
Toe Deformity None Musculoskeletal and connective tissue disorders None View
Prostate Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Post Herpetic Neuralgia None Nervous system disorders None View
Urethral Stricture None Renal and urinary disorders None View
Nasal Septum Deviation None Respiratory, thoracic and mediastinal disorders None View
Blood Donor None Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis None Infections and infestations None View
Hypothyroidism None Endocrine disorders None View
Diarrhoea None Gastrointestinal disorders None View
Acute Tonsillitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Cystitis None Infections and infestations None View
Herpes Simplex None Infections and infestations None View
Pneumonia None Infections and infestations None View
Pyelonephritis None Infections and infestations None View
Tonsillitis None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View
Upper Limb Fracture None Injury, poisoning and procedural complications None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Shoulder Pain None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Depression None Psychiatric disorders None View
Dental Implantation None Surgical and medical procedures None View