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 @ 12:00 PM
Ignite Modification Date: 2025-12-25 @ 11:57 AM
NCT ID: NCT00129961
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00129961
Study Brief: Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Calcineurin Inhibitor (CNI) Based Regimen Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. None None 21 47 40 47 View
Sirolimus (SRL) Based Regimen All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography \[HPLC\]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted. None None 15 39 38 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Aneurysm NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arterial anomaly NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarct NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subdural hematoma NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Angioedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin carcinoma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin melanoma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acute kidney failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostatic carcinoma NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neoplasm NON_SYSTEMATIC_ASSESSMENT General disorders None View
Transplant rejection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea and vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lymphoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Accidental Injury NON_SYSTEMATIC_ASSESSMENT General disorders None View
Adenoma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cyst NON_SYSTEMATIC_ASSESSMENT General disorders None View
Drug level decreased NON_SYSTEMATIC_ASSESSMENT General disorders None View
Drug level increased NON_SYSTEMATIC_ASSESSMENT General disorders None View
Face edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flu syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hernia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hormone level altered NON_SYSTEMATIC_ASSESSMENT General disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lab test abnormal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neck pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neoplasm NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pelvic pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tolerance decreased NON_SYSTEMATIC_ASSESSMENT General disorders None View
Transplant rejection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Aneurysm NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arterial anomaly NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomegaly NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular physical finding NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cyanosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemorrhage NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarct NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral vascular disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Retinal artery occlusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombophlebitis superficial NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fecal incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Liver fatty deposit NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Liver function tests abnormal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth ulceration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tongue discoloration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thyroid disorder NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Antinuclear antibody present NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ecchymosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphocytosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Avitaminosis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Creatinine increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Glucose tolerance decreased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercholesteremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperlipemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Lactic dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Peripheral edema NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Sgpt increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Thirst NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myopathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteopenia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Plantar fasciitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Synovitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness postural NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Emotional lability NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervousness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subdural hematoma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough increased NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Laryngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung infiltration nos NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Angioedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fungal dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Herpes simplex NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Maculopapular rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritic rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pustular rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin carcinoma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hypertrophy NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Subcutaneous emphysema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abnormal vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Cataract specified NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Ear disorder NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Ear pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eye disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye hemorrhage NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Retinal disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal edema NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Taste perversion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Albuminuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Breast disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hydronephrosis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hydroureter NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney function abnormal NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostatic specific antigen increase NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Testis disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urogenital disorder NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Allergic reaction other than drug NON_SYSTEMATIC_ASSESSMENT General disorders None View
Device malfunction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Local reaction to procedure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Seborrheic keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View