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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
NCT ID:
NCT00541658
Description:
None
Frequency Threshold:
1
Time Frame:
Treatment-emergent Adverse Events (TEAEs) included all Adverse Events (AEs) from the date of first dose of study drug until the patient's Week 52 visit, or until the date the patient exited from the study for those who withdrew prior to the Week 52 visit.
Study:
NCT00541658
Study Brief:
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 5 mg Before Breakfast | 5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB) | None | None | 31 | 307 | 243 | 307 | View |
| 35 mg After Breakfast | 35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week | None | None | 32 | 307 | 250 | 307 | View |
| 35 mg Before Breakfast | 35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week | None | None | 32 | 308 | 264 | 308 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Antidiuretic Hormone Abnormality | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (13.0) | View |
| Anxiety Disorder due to General Medical Condition | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Aortic Valve Stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Bacterial Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Benign Breast Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Bladder Transitional Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Body Mass Index Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Breast Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Breast Dysplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Carotid Artery Stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.0) | View |
| Cholecystitis Chronic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.0) | View |
| Cholecystitis Infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.0) | View |
| Chondrolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Cystocele | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Cystoscopy Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Device Dislocation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| ECG Signs of Myocardial Ischaemia | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Emotional Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Exercise Tolerance Decreased | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Female Genital Tract Fistula | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Femoral Neck Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Fibula Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Gastric Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Guillain-Barre Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Hiatus Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Humerous Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Hyperparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (13.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Hypertensive Heart Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Inguinal Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Ischaemic Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Joint Instability | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Lung Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Macular Degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Mengitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Mitral Valve Incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Oedematous Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Ovarian Cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Pancreatic Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Parapsoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Parkinson's Disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Pelvic Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Pneumococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Pulmonary Microemboli | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Radius Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Renal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Sigmoiditis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Sinuitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Spinal Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Stress Urinary Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Superventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Therapeutic Agent Toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Tibia Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Upper Limb Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Urinary Bladder Polyp | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Uterine Prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Vaginal Prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.0) | View |
| Varicose Vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Vasculitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Vertigo Positional | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.0) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Benign Neoplasm of Adrenal Gland | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | View |
| Cerebrovascular Accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Deafness Unilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.0) | View |
| Femur Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Major Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Pancreatitis Acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Thoracic Vertebral Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Abdominal Pain Lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (13.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Blood Parathyroid Hormone Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Blood Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (13.0) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Cholethiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (13.0) | View |
| Colonic Polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (13.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Dental Caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Dermatitis Allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Diverticulum Intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Drug Intolerance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Foot Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Gastrointestinal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gastrointestinal Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Herpes Zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Hiatus Hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Hot Flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Hyperchlorhydria | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (13.0) | View |
| Hyperparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (13.0) | View |
| Hyperparathyroidism Secondary | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (13.0) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (13.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Hypoparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (13.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Influenza Like Illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Joint Sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Memory Impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (13.0) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Pain in Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.0) | View |
| Radius Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (13.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.0) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Sleep Disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (13.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |
| Supraventricular Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.0) | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | View |
| Tooth Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Varicose Vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (13.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (13.0) | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.0) | View |