Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT01466660
Description: Treated set included all patients who were dispensed with and documented to have taken at least one dose of study medication. This set of patients was used for the evaluation of safety.
Frequency Threshold: 5
Time Frame: From first drug administration until 28 days after last drug administration, up to 2405 days. For All-Cause Mortality: From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.
Study: NCT01466660
Study Brief: LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Afatinib Afatinib film-coated tablets administered orally, once daily. Starting dose was 40 milligram (mg), dose escalation to 50mg was allowed after completing one 28-day treatment course, dose reduction to 40mg, 30mg or 20mg was required in the presence of protocol-defined adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal. 126 None 75 160 157 160 View
Gefitinib Gefitinib film-coated tablets, administered orally, once daily. Starting dose was 250mg, the investigator was allowed to modify dosing in the presence of drug-related adverse events. Continuous daily dosing until disease progression, occurrence of unacceptable adverse events, or other reason necessitating withdrawal. 132 None 64 159 159 159 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphoid tissue hyperplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cushing's syndrome SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Hepatic haemorrhage SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Empyema SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Skin bacterial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Foreign body aspiration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Wound haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Spinal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Cerebellar haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cerebellar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Metastases to central nervous system SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Metastases to meninges SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Renal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Embolic cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Nervous system disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Paraneoplastic encephalomyelitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Paraplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.0 View
Cervical dysplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.0 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Intertrigo SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Pain of skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Pneumonectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 22.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Bone marrow failure SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Sudden hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 22.0 View
Macular degeneration SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Cancer pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Cholesteatoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Cerebral disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Large intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
Endometrial adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Anal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nasal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 22.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Nasal dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.0 View