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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT02511106
Description:
Please note the "All-Cause Mortality" section has more subjects at risk because it is based off of the Full Analysis Set, which includes all randomized participants.
The remainder of the AE sections are based off the Safety Analysis Set, which includes all patients who received at least 1 dose of study treatment.
Frequency Threshold:
5
Time Frame:
Adverse events with onset date on or after the date of first dose up to and including 28 days following discontinuation of study treatment and before starting subsequent cancer therapy, up to approximately 3 years. All-Cause Mortality assessed up to approximately 7 years.
Study:
NCT02511106
Study Brief:
AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Neck mass | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Pathological fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Bladder cancer stage 0, with cancer in situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Chronic lymphocytic leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Invasive ductal breast carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Myeloproliferative neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Tachycardia paroxysmal | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Lacunar infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Vocal cord paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Renal colic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Otolithiasis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.1 | View |
| Ureterolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.1 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| Intermenstrual bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| Uterine polyp | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Tympanic membrane perforation | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Laryngeal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Nasal polyps | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 25.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Venous thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Abdominal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Gastric polyps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Intestinal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Large intestine perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Cholangitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 25.1 | View |
| Contrast media allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 25.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Biliary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Covid-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Cataract operation complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Comminuted fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Craniocerebral injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Ligament injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| Subdural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Thoracic vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.1 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Bone hypertrophy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Skin fissures | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 25.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Electrocardiogram qt prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | View |