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 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
NCT ID:
NCT03725202
Description:
None
Frequency Threshold:
5
Time Frame:
All-cause mortality and adverse events were collected from the time informed consent was signed through 06 February 2024. Median time on follow-up was for 378 days for Pbo (Period 1); 377 days for Upa 7.5 mg (Period 1); 378 days for Upa 15 mg (Period 1); 289 days for Pbo -> Pbo (Period 2); 364 days for 7.5 mg Upa -> 7.5 mg Upa (Period 2); 348 days for 7.5 mg Upa -> Pbo (Period 2); 363.5 days for 15 mg Upa -> 15 mg Upa (Period 2); and 363 days for 15 mg Upa -> Pbo (Period 2).
Study:
NCT03725202
Study Brief:
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo + 52-week CS Taper | Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1. | 2 | None | 24 | 112 | 88 | 112 | View |
| 7.5 mg Upadacitinib + 26-week CS Taper | Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1. | 0 | None | 14 | 107 | 88 | 107 | View |
| 15 mg Upadacitinib + 26-week CS Taper | Participants randomized to receive 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1. | 3 | None | 50 | 210 | 174 | 210 | View |
| Placebo + 52-week CS Taper -> Placebo | Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR who had absence of GCA signs and symptoms and were CS-free at the Week 52 visit who were randomized to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2. | 0 | None | 6 | 43 | 27 | 43 | View |
| 7.5 mg Upadacitinib + 26-week CS Taper -> 7.5 mg Upadacitinib | Participants randomized to receive 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2. | 0 | None | 5 | 39 | 21 | 39 | View |
| 7.5 mg Upadacitinib + 26-week CS Taper -> Placebo | Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2. | 0 | None | 0 | 14 | 12 | 14 | View |
| 15 mg Upadacitinib + 26-week CS Taper -> 15 mg Upadacitinib | Participants randomized to receive15 mg upadacitinib tablets administered orally once daily (QD) in Period 2. | 0 | None | 11 | 92 | 61 | 92 | View |
| 15 mg Upadacitinib + 26-week CS Taper -> Placebo | Participants randomized to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2. | 0 | None | 4 | 35 | 30 | 35 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.1 | View |
| PANCREATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| SUBSTANCE-INDUCED PSYCHOTIC DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 26.1 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| ENDOCARDITIS FIBROPLASTICA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| MITRAL VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| MYOCARDIAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| TRICUSPID VALVE INCOMPETENCE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.1 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 26.1 | View |
| TOXIC NODULAR GOITRE | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 26.1 | View |
| DIPLOPIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| GLAUCOMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| MACULAR OEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| RETINAL DETACHMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| COLITIS ISCHAEMIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| COLITIS ULCERATIVE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| GASTROINTESTINAL ANGIODYSPLASIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| MALLORY-WEISS SYNDROME | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| CHOLECYSTITIS CHRONIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| HEPATITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.1 | View |
| DRUG HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 26.1 | View |
| ASPERGILLUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| COVID-19 PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| DEVICE RELATED INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| ERYSIPELAS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| FEBRILE INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| GASTROENTERITIS CLOSTRIDIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| GENITOURINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| INTERVERTEBRAL DISCITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| OPHTHALMIC HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| PNEUMONIA BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| PSEUDOMONAL BACTERAEMIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| SALMONELLOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| SEPTIC ARTHRITIS STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| WOUND INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| FOOT FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| HEAD INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| INFUSION RELATED REACTION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| PATELLA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| RADIUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| SPINAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| THORACIC VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| TROPONIN T INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| LUMBAR SPINAL STENOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| MENISCAL DEGENERATION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| VERTEBRAL FORAMINAL STENOSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| LUNG ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| MALIGNANT NEOPLASM OF AMPULLA OF VATER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| MYXOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| PAPILLARY THYROID CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| PROSTATIC ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| SQUAMOUS CELL CARCINOMA OF LUNG | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| SQUAMOUS CELL CARCINOMA OF SKIN | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| TONSIL CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | View |
| CEREBELLAR ATAXIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| CEREBRAL AMYLOID ANGIOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| CEREBROSPINAL FISTULA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| QUADRANTANOPIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| HAEMATURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 26.1 | View |
| CERVICAL DYSPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| HAEMOTHORAX | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| PULMONARY MASS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| SKIN ULCER | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| AORTIC DISSECTION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| AORTIC THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| ARTERIOSCLEROSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| GIANT CELL ARTERITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| PERIPHERAL EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| CYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| TOOTH ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| TOOTH INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.1 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| HYPERCHOLESTEROLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.1 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| GREATER TROCHANTERIC PAIN SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| JOINT EFFUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.1 | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| INGROWING NAIL | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| RASH MACULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.1 | View |
| GIANT CELL ARTERITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.1 | View |
| CATARACT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| OCULAR HYPERAEMIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 26.1 | View |
| ABDOMINAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.1 | View |
| LIGAMENT SPRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| LIMB INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.1 | View |
| BLOOD PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| GLUCOSE URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |
| OCCULT BLOOD POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 26.1 | View |