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 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
NCT ID:
NCT01871805
Description:
Safety population
Frequency Threshold:
5
Time Frame:
Baseline to up to 28 days after the last dose of alectinib (up to 284 weeks)
Study:
NCT01871805
Study Brief:
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Alectinib 460 mg (Fed): Phase I | Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons. | 4 | None | 2 | 7 | 7 | 7 | View |
| Alectinib 600 mg (Fed): Phase I | Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons. | 6 | None | 6 | 13 | 12 | 13 | View |
| Alectinib 760 mg (Fed): Phase I | Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons. | 2 | None | 0 | 7 | 7 | 7 | View |
| Alectinib 900 mg (Fed): Phase I | Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons. | 9 | None | 1 | 13 | 13 | 13 | View |
| Alectinib 600 mg (Fed): Phase II | Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons. | 45 | None | 21 | 87 | 85 | 87 | View |
| Alectinib 300 mg (Fasted): Phase I | Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons. | 7 | None | 1 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Chronic myeloid leukaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 20.0 | View |
| Brain oedema | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Cerebral ventricle dilatation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Embolic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Drug-induced liver injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 20.0 | View |
| Hyperammonaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Bile duct obstruction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 20.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Radiation necrosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Stroke-like migraine attacks after radiation therapy | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Tumour necrosis | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 20.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Hypercapnia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Injection site haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Injection site reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Groin pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Joint swelling | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Muscle fatigue | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Musculoskeletal stiffness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Myopathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Electrocardiogram PR Prolongation | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Blood triglycerides increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Activated partial thromboplastin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Blood cholesterol increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Blood phosphorus increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Ejection fraction decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Heart rate irregular | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Neutrophil count | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Oral disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Burning sensation | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Amnesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Aura | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Brain oedema | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Memory impairment | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Narcolepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Sinus headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Fungal skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Rash pustular | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypertriglyceridaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypophosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Fluid retention | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Dyslipidaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Paranasal sinus discomfort | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Sinus congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Upper respiratory tract congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Upper-airway cough syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Photosensitivity reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Rash macular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Dermatitis acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Dermatitis allergic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Night sweats | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 20.0 | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Atrioventricular block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Bundle branch block left | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Diastolic dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Panic attack | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 20.0 | View |
| Visual impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Eye irritation | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Eyelid oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Periorbital oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Vitreous floaters | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 20.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Post lumbar puncture syndrome | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Radiation injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Thermal burn | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Upper limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 20.0 | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 20.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 20.0 | View |
| Micturition urgency | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 20.0 | View |
| Renal cyst | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 20.0 | View |
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 20.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 20.0 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 20.0 | View |
| Flushing | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Thrombophlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 20.0 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 20.0 | View |
| Tanning | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA Version 20.0 | View |
| Ventricular extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 20.0 | View |
| Hypoacusis | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 20.0 | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Gingival swelling | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Noninfective gingivitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 20.0 | View |
| Axillary pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Peripheral swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 20.0 | View |
| Babesiosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Infective exacerbation of chronic obstructive airways disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Onychomycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 20.0 | View |
| Animal bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Fractured sacrum | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 20.0 | View |
| Blood testosterone decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Electrocardiogram abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Prothrombin time prolonged | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 20.0 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypercholesterolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hyperphosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 20.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Joint effusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | View |
| Dizziness postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 20.0 | View |
| Hypertonic bladder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 20.0 | View |
| Dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |
| Sinus pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | View |