Adverse Events Module

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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 @ 12:22 AM
Ignite Modification Date: 2025-12-25 @ 10:26 PM
NCT ID: NCT02320058
Description: None
Frequency Threshold: 5
Time Frame: From first dose to 100 days post last dose (Up to 68 months)
Study: NCT02320058
Study Brief: An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity. 29 None 50 101 97 101 View
Cohort B Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity. 10 None 14 18 18 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
IMMUNE-MEDIATED NEPHRITIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
NEPHRITIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
METABOLIC ENCEPHALOPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PARTIAL SEIZURES SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PERIPHERAL MOTOR NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PERIPHERAL SENSORY NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
SEIZURE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
GRANULOMATOUS PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
LUNG DISORDER SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
RASH MACULO-PAPULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
EMBOLISM SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.1 View
WARM TYPE HAEMOLYTIC ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.1 View
ACUTE CORONARY SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
ANGINA PECTORIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
MYOCARDITIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
ADRENAL INSUFFICIENCY SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
HYPERTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
HYPOPHYSITIS SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.1 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
DUODENITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
IMMUNE-MEDIATED PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
MUCOSAL INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.1 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.1 View
HEPATITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.1 View
CYTOKINE RELEASE SYNDROME SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.1 View
BACILLUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
CELLULITIS ORBITAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
CLOSTRIDIUM DIFFICILE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
MENINGITIS BACTERIAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
ORBITAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
RASH PUSTULAR SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
SEPTIC SHOCK SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
SKIN INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
SOFT TISSUE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
STAPHYLOCOCCAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
SYNOVIAL RUPTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
AMYLASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
LIPASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
TYPE 1 DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
MYOSITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
RHABDOMYOLYSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
INTRACRANIAL TUMOUR HAEMORRHAGE SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.1 View
MALIGNANT NEOPLASM PROGRESSION SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.1 View
TUMOUR PSEUDOPROGRESSION SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.1 View
BRAIN OEDEMA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
CEREBRAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
DYSAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
HAEMORRHAGE INTRACRANIAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
HEMIPARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
ISCHAEMIC STROKE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
LACUNAR INFARCTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
THYROIDITIS SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
IRITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.1 View
OCULAR HYPERAEMIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.1 View
PHOTOPHOBIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.1 View
PHOTOPSIA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.1 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.1 View
VISUAL ACUITY REDUCED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.1 View
VISUAL IMPAIRMENT SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.1 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
ABDOMINAL TENDERNESS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
APHTHOUS ULCER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
ASCITES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
LYMPHOCYTE COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
WEIGHT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
HYPERGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
HYPERKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
ATAXIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
BALANCE DISORDER SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
COORDINATION ABNORMAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
DYSARTHRIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
HAEMORRHAGE INTRACRANIAL SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
LETHARGY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
MEMORY IMPAIRMENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PAROSMIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PERIPHERAL MOTOR NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PERIPHERAL SENSORY NEUROPATHY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
PRESYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
SEIZURE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.1 View
CONFUSIONAL STATE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.1 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 23.1 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
NEPHRITIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
NOCTURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.1 View
VULVOVAGINAL DRYNESS SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 23.1 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
DYSPHONIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
PHOTOSENSITIVITY REACTION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
SINUS TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 23.1 View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.1 View
TINNITUS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.1 View
ADRENAL INSUFFICIENCY SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
HYPERTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
HYPOGONADISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
HYPOPHYSITIS SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 23.1 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
ORAL DISORDER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.1 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
DISEASE PROGRESSION SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
GAIT DISTURBANCE SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
LOCALISED OEDEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
OEDEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.1 View
CYTOKINE RELEASE SYNDROME SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.1 View
HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 23.1 View
CRYPTOCOCCAL FUNGAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
IMPETIGO SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
ORAL CANDIDIASIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
TINEA CRURIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
ESCHAR SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
PROCEDURAL PAIN SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
AMYLASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
BLOOD ALKALINE PHOSPHATASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
BLOOD BILIRUBIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
BLOOD CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
LIPASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
LIVER FUNCTION TEST INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
HYPOALBUMINAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
HYPOMAGNESAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
HYPOPHOSPHATAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 23.1 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
GROIN PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
PAIN IN JAW SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
TUMOUR PSEUDOPROGRESSION SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 23.1 View
AMNESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
APHASIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
INCREASED BRONCHIAL SECRETION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
PNEUMONITIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
TACHYPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
WHEEZING SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 23.1 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
DERMATITIS ACNEIFORM SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
MACULE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
ONYCHOMADESIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
RASH MACULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
RASH MACULO-PAPULAR SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
RASH PRURITIC SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
SKIN HYPOPIGMENTATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
VITILIGO SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
HOT FLUSH SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 23.1 View