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 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
NCT ID:
NCT03361956
Description:
Safety analysis set included all participants who received at least one dose of the study agent and all safety endpoints analyzed by the treatment arm as treated.
Frequency Threshold:
2
Time Frame:
From screening to end of study (up to Week 80) (Screening period of 8 weeks + Initial treatment phase of 24 weeks [Week 0 to Week 24] + 24 week Follow-up [Week 0 to Week 48], and Treatment extension phase of 24 weeks [Week 24 to Week 48] + 24 week follow-up [Week 24 to Week 72]= Week 80)
Study:
NCT03361956
Study Brief:
An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus 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 |
|---|---|---|---|---|---|---|---|---|
| Initial Treatment Phase: Parts A and B: Pooled Placebo + Nucleos(t)Ide Analog (NA) | Virologically suppressed (who were on entecavir \[ETV\] or tenofovir disoproxil fumarate \[TDF\] for at least 12 months prior to screening and had hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\] \<60 IU/ml) or currently not treated (who didn't receive any HBV treatment 6 months prior to baseline) participants received matching placebo to JNJ-56136379 (75 milligrams \[mg\] or 250 mg) plus 1 tablet of NA (either 0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 1 | 43 | 9 | 43 | View |
| Initial Treatment Phase: Part A: JNJ-56136379 75 mg (Open Label) | Currently not treated participants received 3\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 1 | 28 | 18 | 28 | View |
| Initial Treatment Phase: Part A: JNJ-56136379 75 mg + NA | Virologically suppressed or currently not treated participants received 3\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 0 | 66 | 19 | 66 | View |
| Initial Treatment Phase: Part B: JNJ-56136379 250 mg (Open-label) | Currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 once daily from Day 1 to Week 24 during the initial treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 0 | 32 | 12 | 32 | View |
| Initial Treatment Phase: Part B: JNJ-56136379 250 mg + NA | Virologically suppressed or currently not treated participants received 2\*100 mg and 2\*25 mg tablets of JNJ-56136379 plus 1 tablet of NA either (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24 during treatment phase. Participants who did not participate in the treatment extension phase after Week 24 were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 1 | 63 | 11 | 63 | View |
| Treatment Extension Phase: Parts A and B: Pooled Placebo + NA | Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 0 | 33 | 25 | 33 | View |
| Treatment Extension Phase: Part A: JNJ-56136379 75 mg (Open Label) | Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued treatment with JNJ-56136379 75mg from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 0 | 3 | 2 | 3 | View |
| Treatment Extension Phase: Part A: JNJ-56136379 75 mg + NA | Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 75 mg treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 4 | 43 | 38 | 43 | View |
| Treatment Extension Phase: Part B: JNJ-56136379 250 mg (Open-label) | Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants who completed the extension phase were followed up and received treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 0 | 20 | 15 | 20 | View |
| Treatment Extension Phase: Part B: JNJ-56136379 250 mg + NA | Participants who completed the initial 24 weeks of treatment with a virologic response by Week 20 and without experiencing any safety concerns precluding continued JNJ-56136379 treatment from Week 24 to Week 48 in the treatment extension phase. Participants those who completed the extension phase were followed up and continued treatment with only NA (either ETV or TDF) for additional 24 weeks. | 0 | None | 3 | 48 | 42 | 48 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphadenitis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Cardiac Failure Acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Myocarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Toxic Shock Syndrome Streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Ligament Rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Post-Traumatic Neck Syndrome | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Intervertebral Disc Protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Muscle Necrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Lung Adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | View |
| Ovarian Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Iron Deficiency Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Neutrophilia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 23.0 | View |
| Atrioventricular Block First Degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Atrioventricular Block Second Degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Bundle Branch Block Right | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Defect Conduction Intraventricular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 23.0 | View |
| Ear Congestion | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 23.0 | View |
| Motion Sickness | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 23.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 23.0 | View |
| Tympanic Membrane Perforation | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 23.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 23.0 | View |
| Goitre | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 23.0 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 23.0 | View |
| Conjunctivitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 23.0 | View |
| Dry Eye | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 23.0 | View |
| Swelling of Eyelid | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 23.0 | View |
| Xerophthalmia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 23.0 | View |
| Abdominal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Abdominal Distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Abdominal Pain Lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Abdominal Tenderness | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Chronic Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Dental Caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Dry Mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Duodenal Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Duodenitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Epigastric Discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Eructation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Faeces Hard | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Gingival Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Glossodynia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Haemorrhoidal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Hiatus Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Hypoaesthesia Oral | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Mouth Ulceration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Odynophagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Periodontal Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Tongue Disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Tooth Impacted | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 23.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Chest Discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Cyst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Non-Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Thirst | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 23.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.0 | View |
| Gallbladder Polyp | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.0 | View |
| Hepatic Cyst | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.0 | View |
| Hepatic Pain | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.0 | View |
| Hepatic Steatosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.0 | View |
| Ocular Icterus | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 23.0 | View |
| Seasonal Allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 23.0 | View |
| Alveolar Osteitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Asymptomatic Bacteriuria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Bronchitis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Ear Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Furuncle | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Helicobacter Gastritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Hepatitis B | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Herpes Virus Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Laryngitis Viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Localised Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pharyngitis Streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Pulpitis Dental | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Suspected Covid-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Tooth Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Vaginal Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Viral Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Viral Tracheitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Viral Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Vulvitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 23.0 | View |
| Arthropod Bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Corneal Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Eye Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Gingival Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Joint Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Ligament Sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Muscle Strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Skin Abrasion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Skin Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Wound | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 23.0 | View |
| Alanine Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Amylase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Aspartate Aminotransferase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Bilirubin Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Calcium Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Cholesterol Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Creatine Phosphokinase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Creatinine Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Glucose Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Magnesium Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Potassium Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Triglycerides | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Blood Triglycerides Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Electrocardiogram QT Prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Electrocardiogram T Wave Inversion | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Glomerular Filtration Rate Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Hepatic Enzyme Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Hepatitis B Dna Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Lipase Increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Protein Urine Present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Sars-Cov-2 Test Positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Ultrasound Liver Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Urinary Sediment Present | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Urine Analysis Abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Urine Leukocyte Esterase Positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 23.0 | View |
| Abnormal Loss of Weight | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Diabetes Mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Glucose Tolerance Impaired | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyperphosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hyperuricaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Impaired Fasting Glucose | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Iron Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Vitamin D Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 23.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Fibromyalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Joint Noise | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Muscle Spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Musculoskeletal Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Musculoskeletal Discomfort | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Musculoskeletal Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Musculoskeletal Stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Neck Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Spinal Stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Trigger Finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | View |
| Leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | View |
| Lipoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | View |
| Carpal Tunnel Syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Cerebral Ischaemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Disturbance in Attention | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Memory Impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Neuromuscular Pain | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Parkinson's Disease | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Poor Quality Sleep | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 23.0 | View |
| Aggression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Attention Deficit Hyperactivity Disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Dysphoria | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Irritability | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Suicidal Ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 23.0 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Urinary Incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Urinary Tract Discomfort | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 23.0 | View |
| Adenomyosis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Cervical Polyp | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Menorrhagia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Menstruation Irregular | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Vaginal Discharge | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 23.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Dry Throat | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Nasal Polyps | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Respiratory Disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Rhinitis Allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Sinus Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Upper Respiratory Tract Inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Alopecia Areata | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Dermatitis Acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Ingrowing Nail | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Lichen Planus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Night Sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Skin Discolouration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Skin Lesion | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 23.0 | View |
| Abortion Induced | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 23.0 | View |
| Dental Implantation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 23.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |
| Hypertensive Crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 23.0 | View |