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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
NCT ID:
NCT00650767
Description:
An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.
Frequency Threshold:
0
Time Frame:
Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.
Study:
NCT00650767
Study Brief:
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
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 | Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets. Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. | None | None | 1 | 49 | 20 | 49 | View |
| ARRY-438162: 10 mg Bid | Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. | None | None | 1 | 49 | 25 | 49 | View |
| ARRY-438162: 40 mg qd | Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. | None | None | 1 | 50 | 39 | 50 | View |
| ARRY-438162: 20 mg Bid | Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo. | None | None | 0 | 50 | 42 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| BRONCHOPNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| MYOCARDIAL INFARCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| EROSIVE OESOPHAGITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| GASTRITIS EROSIVE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| ABDOMINAL INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| CHEST INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| THROMBOPHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DIARRHOEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| ABDOMINAL PAIN UPPER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| GASTRITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| DYSPEPSIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| ABDOMINAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| APHTHOUS STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| DRY MOUTH | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| ENTEROCOLITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| FLATULENCE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| STOMATITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| ABDOMINAL DISTENSION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| ANAL FISSURE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| CHEILITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| EROSIVE OESOPHAGITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| FOOD POISONING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| GASTRITIS EROSIVE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| IRRITABLE BOWEL SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| TONGUE DISORDER | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| TOOTHACHE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| HAEMORRHOIDAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| HIATUS HERNIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (11.0) | View |
| RASH | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| DERMATITIS ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| ACNE | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| ROSACEA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| URTICARIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| ALOPECIA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| ECZEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| PRURITUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| RASH ERYTHEMATOUS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| RASH PAPULAR | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| SKIN ULCER | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| ECCHYMOSIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| LIVEDO RETICULARIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| ONYCHOCLASIS | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| PERIORBITAL OEDEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| PIGMENTATION DISORDER | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| PLANTAR ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| PRURIGO | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| URINARY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| BRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| FOLLICULITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| GASTROENTERITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| RASH PUSTULAR | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| CYSTITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| INFLUENZA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| ACUTE TONSILLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| BRONCHOPNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| EAR INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| GASTROENTERITIS VIRAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| GENITAL HERPES | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| HELICOBACTER GASTRITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| HERPES SIMPLEX | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| NASOPHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| PARONYCHIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| PHARYNGITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| PHARYNGOTONSILLITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| PNEUMONIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| TRACHEITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| TRACHEOBRONCHITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| VULVOVAGINAL MYCOTIC INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| ASYMPTOMATIC BACTERIURIA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (11.0) | View |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| BLOOD PRESSURE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| TRANSAMINASES INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| WEIGHT INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| ALANINE AMINOTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| BLOOD PRESSURE SYSTOLIC ABNORMAL | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| ELECTROCARDIOGRAM QT PROLONGED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| HEPATIC ENZYME INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| LIVER FUNCTION TEST ABNORMAL | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| BLOOD GLUCOSE INCREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| RHEUMATOID ARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| BACK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| MUSCULOSKELETAL CHEST PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| OSTEOARTHRITIS | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (11.0) | View |
| SYNOVIAL CYST | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| ARTHRALGIA | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| OEDEMA PERIPHERAL | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| FACE OEDEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| FATIGUE | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| GENERALISED OEDEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| INFLUENZA LIKE ILLNESS | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| PYREXIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| THIRST | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| ASTHENIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (11.0) | View |
| HEADACHE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| DIZZINESS | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| HYPOTONIA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| SCIATICA | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| SOMNOLENCE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| ABDOMINAL INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| ARTHROPOD BITE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| CHEST INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| CONTUSION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| EXCORIATION | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| JOINT INJURY | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| VERTIGO | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (11.0) | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| DYSLIPIDAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| VITAMIN D DEFICIENCY | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| DYSURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| URINARY BLADDER POLYP | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| HAEMATURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| PROTEINURIA | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| RENAL COLIC | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (11.0) | View |
| GENITAL DISCHARGE | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| HYPOMENORRHOEA | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (11.0) | View |
| LYMPHOCYTOSIS | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| NEUTROPENIA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| SPONTANEOUS HAEMATOMA | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (11.0) | View |
| CHOLELITHIASIS | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (11.0) | View |
| TREMOR | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (11.0) | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| PHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| THROMBOPHLEBITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| VASCULITIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (11.0) | View |
| ANGINA PECTORIS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| ATRIOVENTRICULAR BLOCK | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| LEFT VENTRICULAR HYPERTROPHY | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| MITRAL VALVE INCOMPETENCE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| MYOCARDIAL ISCHAEMIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| PALPITATIONS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| TACHYCARDIA | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| TRICUSPID VALVE INCOMPETENCE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| MYOCARDIAL INFARCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (11.0) | View |
| CONJUNCTIVAL HAEMORRHAGE | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| CONJUNCTIVITIS | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| EYE SWELLING | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| SCOTOMA | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| VISUAL ACUITY REDUCED | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (11.0) | View |
| ALLERGIC SINUSITIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| EPISTAXIS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| HYPOXIA | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| PHARYNGOLARYNGEAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| UPPER RESPIRATORY TRACT INFLAMMATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| FALL | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (11.0) | View |
| MUSCULOSKELETAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |
| BONE PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | View |