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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT02125461
Description:
TEAEs included events from first dose of study drug until the earlier of 90 days after last dose or date of first subsequent therapy. 473 and 236 patients in the durvalumab and placebo groups, respectively, received treatment but 2 patients randomized to placebo received 1 dose of durvalumab in error and are included in the durvalumab safety analysis set.
Frequency Threshold:
5
Time Frame:
Serious and Other (non-serious) treatment-emergent adverse event (TEAE) data collected during the 12-month treatment period. All-cause mortality (death due to any cause) collected for entire duration of the study. Assessed until 11 Jan 2021 DCO for completion of long-term survival; approximately 5 years from last patient enrolled.
Study:
NCT02125461
Study Brief:
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Durvalumab (MEDI4736) | Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months. | 262 | None | 138 | 475 | 436 | 475 | View |
| Placebo | Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months. | 154 | None | 54 | 234 | 212 | 234 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Arrhythmia supraventricular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Arteriospasm coronary | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Cardiac disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Eosinophilic myocarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Macular hole | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Lung abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia adenoviral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia streptococcal | 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 |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Papillary thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Oesophageal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Infusion site extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 23.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Haemophilus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Lower respiratory tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| West Nile viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Traumatic intracranial haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Myocardial necrosis marker increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Malignant melanoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Small intestine carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Acute interstitial pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Bronchopleural fistula | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Haemoptysis | 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 |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Sarcoidosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.1 | View |
| Chest wall abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Endotoxaemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Necrotising fasciitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia haemophilus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia necrotising | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Post procedural fistula | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Radiation oesophagitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Radiation pneumonitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Brain natriuretic peptide increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Iron overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Type 1 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Myopathy | 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 |
| Polymyalgia rheumatica | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Giant cell tumour of tendon sheath | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Adjustment disorder with mixed anxiety and depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Alcohol withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Glomerulonephritis membranous | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Renal tubular acidosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.1 | View |
| Calculus prostatic | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.1 | View |
| Acquired tracheo-oesophageal fistula | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Bronchial obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |
| Aortic dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Jugular vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Vena cava thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Non-cardiac chest pain | 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 |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Radiation pneumonitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.1 | View |
| Hypokalaemia | 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 |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | View |
| Myalgia | 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 |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.1 | View |
| Dyspnoea | 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 |
| Dry skin | 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 |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 23.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 23.1 | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 23.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | View |