Adverse Events Module

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 @ 2:21 AM
Ignite Modification Date: 2025-12-26 @ 12:53 AM
NCT ID: NCT00486434
Description: The safety population is all patients randomized who received at least one dose of study medication. There were 7 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
Frequency Threshold: 2
Time Frame: From baseline until 30 days following the end of study.
Study: NCT00486434
Study Brief: Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Arm 0.8mg SMC021 Oral Calcitonin tablet twice daily None None 100 585 548 585 View
Placebo Arm 1 SMC021 Placebo tablet twice daily None None 88 584 520 584 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Bone graft NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Spinal column stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (Unspecified) View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Obesity NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Benign breast neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Colonic polyp NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Knee arthroplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Wrist fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Sick sinus syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Coronary artery dilatation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Hypoacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (Unspecified) View
Goitre NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (Unspecified) View
Hyperparathyroidism NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (Unspecified) View
Macular degeneration NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (Unspecified) View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Anal fissure NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Diverticulum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Gastritis erosive NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Volvulus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Accidental death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Device malfunction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (Unspecified) View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Anal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Erysipelas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Lyme disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Mastoiditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Post procedural infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Pyelonephritis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Foreign body NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Hand fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Jaw fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Ligament rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Lower limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Meniscus lesion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Nerve injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Post lumbar puncture syndrome NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Tendon rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Tibia fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Electrocardiogram T wave abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (Unspecified) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Chondropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Foot deformity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Spondylolisthesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Bile duct cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Cervix carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Lung neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Ovarian cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Rectal cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Squamous cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Uterine cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Uterine leimyoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Cauda equina syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Radiculopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Alcoholism NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Urinary incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (Unspecified) View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (Unspecified) View
Urethral prolapse NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (Unspecified) View
Urinary retension NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (Unspecified) View
Benign prostatic hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (Unspecified) View
Prostatomegaly NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (Unspecified) View
Uterine haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (Unspecified) View
Vaginal prolapse NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (Unspecified) View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Interstitial lung disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Nasal polyps NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Peau d´orange NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Abscess drainage NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Appendicectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Cardial pacemaker insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Gastric bypass NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Lipoma excision NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Radical hysterectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Thyroidectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA (Unspecified) View
Aortic aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Intermittent claudication NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Circulatory collapse NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (Unspecified) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Hypercholesterolemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (Unspecified) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Viral infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (Unspecified) View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (Unspecified) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Joint sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (Unspecified) View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View