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: 2025-12-24 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT00603304
Description: The number of participants at risk was determined by the number of participants that were randomized and included in the modified intention to treat analyses.
Frequency Threshold: 1
Time Frame: Collected over 72 weeks
Study: NCT00603304
Study Brief: Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Saw Palmetto One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks. None None 18 176 138 176 View
Placebo One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks. None None 17 181 139 181 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elective knee replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elective plastic surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elective repair of abdominal aortic aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Elective tonsillectomy and deviated nasal septum repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mestatic recurrent follicular thyroid carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatic Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Appendectomy for appendicitis NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Appendectomy for ruptured appendix NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Automobile accident with multiple injuries NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back surgery for a lumbar spinal connective tissue cyst NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bacterial epididymitis requiring intravenous antibiotics NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bladder Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebellar stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Colon resection for a polyp NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Elective knee replacement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Episode of atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gross hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalized after pacemaker insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalized for abdominal pain, underwent laparascopic cholecystectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalized for cellulitis of the elbow, required intravenous antibiotics NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalized for chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalized for chest pain due to coronary artery disease, underwent revascularization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalized for chest pain that proved noncardiac after the study NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalized for diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalized for hypotension due to pneumonia and chronic kidney disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitalized for knee pain secondary to torn vastus lateralis muscle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalized for pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalized for radioactive iodine treatment for thyroid cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Inferior wall myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lower gastointestinal diverticular bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis secondary to a pelvic fracture NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Severe Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Small bowel obstruction requiring laparoscopy lysis of adhesions NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Syncope with transient high grade atrioventricular block NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper gastrointestinal bleeding requiring transfusion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cold NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Frost bite to bronchial tubes NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increase mucus NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Strep Throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sneezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore Throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Post Nasal Drip NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pre-Existing Lower Back Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tonsilectomy and Deviated Septum Repair NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gout NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Foot Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Tendonitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hip Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Elbow Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Broken Tooth NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoporosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hernia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Facial Edema NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
C-Spine Degenerative Disease NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bruised Ribs/Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fore Arm Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lump in Right Calf NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spinal Stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hand Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Plantar Fascitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Toe Surgery NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Leg Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee Replacement NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Groin Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteopenia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Jaw Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sciatic Nerve Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sore Coccyx NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wrist Surgery NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Decreased Libido NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney Stones NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Elevated PSA NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Testicular Pain NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tip of Penis Swollen NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
BPH Symptoms NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain in Groin NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostatitis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Small Spermatocele found in physical exam NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostate nodule left lobe NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Peyronies Disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increase Firmness Erection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Anal Itching NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Epididymitis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increased PVR NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Trace WBC in Urine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urological Disorder - Bloating NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pains NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Barrett's Esophagus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatty Liver NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
White Stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upset Stomach/Flu NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Black Stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colon Polyp NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Emesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Irritable Bowel Syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal Itching NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View