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: 2025-12-24 @ 9:32 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT00705432
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00705432
Study Brief: Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PEG + RBV Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. None None 31 363 353 363 View
BOCEPREVIR + PEG + RBV - 24 WEEKS Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. * At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. * At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up. None None 42 368 365 368 View
BOCEPRIVIR + PEG + RBV - 44 WEEKS Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. None None 45 366 363 366 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
APLASIA PURE RED CELL SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
LEUKOCYTOSIS SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
PANCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
CARDIO-RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
CORONARY ARTERY OCCLUSION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
HYPERTROPHIC CARDIOMYOPATHY SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.0 View
DEAFNESS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 13.0 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 13.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
OPTIC NEUROPATHY SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
PAPILLOEDEMA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
ABDOMINAL PAIN LOWER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
COLITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
COLONIC POLYP SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GASTRITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
HAEMATEMESIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
HAEMORRHOIDAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
HAEMORRHOIDS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
MALLORY-WEISS SYNDROME SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
PANCREATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
PANCREATITIS ACUTE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
UMBILICAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
DEATH SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
GENERAL PHYSICAL HEALTH DETERIORATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
ENTEROCOLITIS INFECTIOUS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
EPIGLOTTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
INFECTED BITES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
INJECTION SITE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
PERIRECTAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
PNEUMONIA PNEUMOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
SCROTAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
TRACHEOBRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
ACCIDENTAL OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
ALCOHOL POISONING SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
POST PROCEDURAL COMPLICATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
ROAD TRAFFIC ACCIDENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
SPINAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
TRANSFUSION REACTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
VASCULAR PSEUDOANEURYSM SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
WOUND DEHISCENCE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.0 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
FLANK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
GROIN PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
MUSCULOSKELETAL CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
BLADDER CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
COLON CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
HEPATIC NEOPLASM MALIGNANT SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
LUNG ADENOCARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
PANCREATIC CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
PROSTATE CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
CAROTID ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
CEREBRAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
LOSS OF CONSCIOUSNESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
MOTOR NEURONE DISEASE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
MUSCLE SPASTICITY SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
AFFECTIVE DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
ALCOHOL ABUSE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
BIPOLAR I DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
COMPLETED SUICIDE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
DRUG ABUSE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
DRUG DEPENDENCE SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
INTENTIONAL SELF-INJURY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
PSYCHIATRIC DECOMPENSATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
SUICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
SUICIDE ATTEMPT SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
GLOMERULONEPHRITIS MINIMAL LESION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
RENAL TUBULAR NECROSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.0 View
SCROTAL PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
PLEURAL FIBROSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
RASH ERYTHEMATOUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
ALCOHOL USE SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 13.0 View
PHYSICAL ASSAULT SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 13.0 View
CHOLECYSTECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
LARYNGEAL OPERATION SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
SKIN NEOPLASM EXCISION SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 13.0 View
ACCELERATED HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
ARTERIAL THROMBOSIS LIMB SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
HYPERTENSIVE CRISIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
CHOLECYSTITIS ACUTE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
CHOLELITHIASIS OBSTRUCTIVE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.0 View
SARCOIDOSIS SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.0 View
ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
ABSCESS LIMB SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
ATYPICAL MYCOBACTERIAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
BACTERAEMIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
DIVERTICULITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
PERSONALITY DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.0 View
DRY EYE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
INJECTION SITE ERYTHEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
INJECTION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
IRRITABILITY SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.0 View
DISTURBANCE IN ATTENTION SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
MEMORY IMPAIRMENT SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
PARAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
MOOD SWINGS SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.0 View