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 @ 1:10 PM
Ignite Modification Date: 2025-12-25 @ 12:22 PM
NCT ID: NCT00513461
Description: None
Frequency Threshold: 0
Time Frame: Through study completion, an average of 30 weeks.
Study: NCT00513461
Study Brief: Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I (SAMe) Patients receive SAMe PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. S-adenosyl-L-methionine disulfate p-toluene-sulfonate: Given PO laboratory biomarker analysis: Correlative studies immunoenzyme technique: Correlative studies high performance liquid chromatography: Correlative studies None None 5 57 51 57 View
Arm II (Placebo) Patients receive placebo PO QD for weeks 1-4, PO BID for weeks 5-8, and PO TID for weeks 9-24 in the absence of disease progression or unacceptable toxicity. placebo: Given PO laboratory biomarker analysis: Correlative studies immunoenzyme technique: Correlative studies high performance liquid chromatography: Correlative studies None None 3 53 46 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ABDOMINAL DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABDOMINAL PAIN.STATUS POST SPLENIC ARTERY EMBOLIZATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEPATOCELLULAR CARCINOMA NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
LEFT THIGH ABSCESS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
NON-ST ELEVATION MIOCARDIAL INFARCTION NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
SPLENOMEGALY SECONDARY TO PORTAL HYPERTENSION NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
ABDOMINAL CELLULITIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
ANGIOPLASTY OF LEFT HYPOGASTRIC ARTERY, EXTERNAL ILIAC STENT PLACEMENT FOR LEFT LEG NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
NEPHROTIC SYNDROME NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
SMALL BOWEL INFLAMATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL CRAMPS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ABDOMINAL DISCOMFORT NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ALLERGIC RHINITIS NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
ANAL IRRITATION NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ARTHRITIS PAIN, KNEES NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ARTHRITIS PAIN, LOWER BACK NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
ASCITES NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
BAD GAS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
BLACK OUT NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
BLEEDING ESPHAGEAL VARICES NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
BLOOD IN STOOLS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
BLURRED VISION NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
BORDERLINE DIABETES NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
BREAST TENDERNESS NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
BROKEN TOOTH-UNCOMPLICATED NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BRONCHITIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
BRUISING R LEG NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
CELLULITIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
CHEST CONGESTION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CHILLS NON_SYSTEMATIC_ASSESSMENT General disorders None View
CHRONIC ASCITES NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CHRONIC GASTRITIS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CLICKING SOUND IN THE HEAD NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
COLD NON_SYSTEMATIC_ASSESSMENT General disorders None View
COMMON COLD NON_SYSTEMATIC_ASSESSMENT General disorders None View
CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
COUGH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CYST ON PATELLA NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DARK COLORED URINE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
DECREASED INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
DENTAL IMPLANT SURGERY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
DIABETES MELLITUS NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHEA 4-6 STOOLS/DAY NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIFFUSE ABDOMINAL PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DISLOCATION OF LEFT SHOULDER NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
DIZZINESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DRY MOUTH/SALIVARY GLAND NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DRYNESS OF MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
EAR PAIN NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
EARS RINGING NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
ELEVATED AFP NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ELEVATED CREATININE NON_SYSTEMATIC_ASSESSMENT Investigations None View
ELEVATED INR NON_SYSTEMATIC_ASSESSMENT Investigations None View
EXTRA GAS FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
EYE PAIN NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
EYES HURT NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
FACIAL SWELLING OF ALLERGIC ORIGIN NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
FALL, HIP AND BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders None View
FEET AND LEGS CRAMPS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
FEVER NON_SYSTEMATIC_ASSESSMENT General disorders None View
FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FLU NON_SYSTEMATIC_ASSESSMENT General disorders None View
FLU-LIKE SYMPTOMS NON_SYSTEMATIC_ASSESSMENT General disorders None View
FOOD POISONING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FORGETFULNESS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
FRACTURE 5TH R METACARPAL NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
GAS-FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI CONSTIPATION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GUM BLEEDING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HAIR LOSS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
HAPPIER NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HEADACHE-SINUS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HEARTBURN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HEPATIC ENCEPHALOPATHY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HOT FLUSHES NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
HUNGRIER NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
HYPOKALEMIA NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
INCREASE IN FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INCREASE NUMBER OF STOOLS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INCREASE PEE NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
INCREASED DIARRHEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INCREASED FLATULENCE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INCREASED STOMACH PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INCREASED SWEATING NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
INCREASED URINATION NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
INFECTED SEBACEOUS CYST R. AXILA NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
INSOMNIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
INTERMITTENT HEADACHE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
INTESTINAL FLU NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INVOLUNTARY MOVEMENT NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
IRRITABILITY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ITCHINESS ALL OVER THE BODY NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ITCHING NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
JOINT PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
KNEE PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LEFT LEG VASCULAR CLAUDICATION NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LEFT SIDE PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LEG CRAMPS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LOWER BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LOWER BACK SURGERY NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LOWER BACKACHE NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LOWER EXTREMITY EDEMA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MACULOPAPULAR RASH ON TORSO NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
MANIA NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
MEMORY LOSS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MILD RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
MOOD ALTERATION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
MOOD ALTERATION DEPRESSION NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
MOOD ALTERATION-ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
MOOD ALTERATION-HAPPY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
MOOD ALTERATION:ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
MUSCLE CRAMPS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCLE CRAMPS OF BOTH LEGS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCLE MOVEMENT NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCULOSKELETAL PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCULOSKELETAL PAIN (NECK) NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MYALGIA NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NECK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
NOSE BLEEDING NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
OLECRANON BURSITIS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN IN BOTH HANDS AND FEET NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN IN KNEE NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN LEFT SIDE OF CHEST NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN ON ANKLE JOINTS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN ON HIP NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PAIN ON KNEE NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PINCHED NERVE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
QUEASINESS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON BOTH ARMS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RASH ON EXTREMETIES NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
RESPIRATORY TRACT INFECTION NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
RESTLESSNESS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
SHORTNESS OF BREATH NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SINUS PAIN NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SINUSITIS NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SKIN RASH NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SPRAINED ANKLE NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
STIFF NECK NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
STIFFNESS OF JOINTS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
STOMACH ACHE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
STOMACH CRAMPS NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
STOMACH FLU NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
STOMACH PAIN NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
SWEATING NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SWEATING "NIGHT" NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
SWELLING OF ANKLES NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
TICS NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
TINNITUS NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
TIREDNESS FATIGUE NON_SYSTEMATIC_ASSESSMENT General disorders None View
TOOTH EXTRACTION NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
TOOTHACHE NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ULCERATION OF THE LIP NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
UPSET STOMACH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
URINE ODOR NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
VAGINAL IRRITATION NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
VAGINAL YEAST INFECTION NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
VIRAL INFECTION INCLUDING COUGHING NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
VITAMIN D DEFICIENCY NON_SYSTEMATIC_ASSESSMENT Investigations None View
VIVID DREAMS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
WEAKNESS NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
WEIGHT GAIN NON_SYSTEMATIC_ASSESSMENT Investigations None View
WORSENING OF ANXIETY NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
WORSENING OF BACK PAIN NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
WORSENING OF BASELINE DIABETES MELLITUS NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View