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 @ 11:45 AM
Ignite Modification Date:
2025-12-26 @ 10:19 AM
NCT ID:
NCT03227861
Description:
The safety analysis was performed on the Intent-to-treat analysis set (ITT) analysis set during main study (Week 0-48) included all the participants who were randomized and received at least one dose of study treatment in the study and safety analysis set (SAS) was used for the analyses during the extension study (Week 48-96) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug.
Frequency Threshold:
0
Time Frame:
Main study: Up to 48 Weeks; Extension Study: Up to 96 Weeks
Study:
NCT03227861
Study Brief:
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| D/C/F/TAF: Main Study | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. | 0 | None | 10 | 109 | 92 | 109 | View |
| D/C/F/TAF: Extension Study | Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). | 0 | None | 4 | 80 | 45 | 80 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Pancreatitis Acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Abdominal Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Muscle Rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Road Traffic Accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Mania | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Psychotic Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Suicidal Ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Pulmonary Embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Meningitis aseptic | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Hypogonadism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 20.0 | View |
| Lacrimation Increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Photophobia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Abdominal Pain Lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Anogenital Dysplasia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Dental Caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Paraesthesia Oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Peripheral Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Gallbladder Polyp | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 20.0 | View |
| Hepatotoxicity | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 20.0 | View |
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 20.0 | View |
| Acute Hepatitis C | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Anorectal Human Papilloma Virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Conjunctivitis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Genitourinary Chlamydia Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Gonorrhoea | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Oral Herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Pharyngeal Chlamydia Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Pyuria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Secondary Syphilis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Tooth Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Viral Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Exposure to Communicable Disease | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Muscle Strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Procedural Pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Blood Pressure Diastolic Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Abnormal Loss of Weight | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Dyslipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Vitamin D Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Groin Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Tenosynovitis Stenosans | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Seborrhoeic Keratosis | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | View |
| Vulvovaginal Warts | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Adjustment Disorder with Depressed Mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Depressed Mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Major Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Panic Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Cervical Dysplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 20.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Dermatitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Dermatitis Contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Macule | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Pityriasis Rosea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Rash Macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Rash Pruritic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Diastolic Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Systolic Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Skin exfoliation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Breast mass | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 20.0 | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Splenomegaly | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Motion Sickness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 20.0 | View |
| Goitre | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 20.0 | View |
| Blindness Transient | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Photopsia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Abdominal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Anorectal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Duodenogastric Reflux | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Enterocolitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Food Poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Lip Swelling | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Chest Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Hepatic Cyst | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 20.0 | View |
| Hepatic Steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 20.0 | View |
| Drug Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 20.0 | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Abscess Limb | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Acarodermatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Acute Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Anal Chlamydia Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Cellulitis Staphylococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Chlamydial Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Cytomegalovirus Syndrome | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Epididymitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Gastroenteritis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Hepatitis A | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Herpes Zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Oropharyngeal Gonococcal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Otitis Externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Otitis Media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Papilloma Viral Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Pilonidal Cyst | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Proctitis Gonococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Skin Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Syphilis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Vulvovaginal Candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Anal Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Human Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Ligament Sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Post-Traumatic Neck Syndrome | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Blood Pressure Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Body Temperature Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Cardiac Murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Weight Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Gout | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hyperlipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Impaired Fasting Glucose | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Increased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Type 2 Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Cervical Spinal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Flank Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Musculoskeletal Stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Plantar Fasciitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Systemic Lupus Erythematosus | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Tendonitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Trigger Finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Adrenal Adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Abnormal Dreams | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Adjustment Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Adjustment Disorder with Mixed Anxiety and Depressed Mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Alcoholic Hangover | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Bipolar Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Drug Abuse | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Initial Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Mental Status Changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Psychotic Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 20.0 | View |
| Erectile Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 20.0 | View |
| Gynaecomastia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 20.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Productive Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Pulmonary Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Sinus Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Dermal Cyst | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Night Sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Rash Maculo-Papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Rash Papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Seborrhoea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Skin Disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Skin Hypopigmentation | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Essential Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Corneal abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Eosinophilia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |