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 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
NCT ID:
NCT03768505
Description:
None
Frequency Threshold:
0
Time Frame:
AEs were collected for 3 years 9 months
Study:
NCT03768505
Study Brief:
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Zandelisib (ME-401) Open Label | Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS). Zandelisib (ME-401): Zandelisib (ME-401) 60 mg | 35 | None | 69 | 169 | 162 | 169 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Campylobacter gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Autoimmune enteropathy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Enterocolitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastritis erosive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Endometrial cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Aspergillus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Conjunctivitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Cytomegalovirus colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pneumonia viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pseudomonal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Sinusitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Tumour lysis syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition 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 |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Systemic inflammatory response syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Hypertensive cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Toxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Eructation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Glossodynia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Oral pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal rigidity | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Angular cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Autoimmune enteropathy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Faeces soft | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastrointestinal sounds abnormal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastrointestinal wall thickening | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Lip dry | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Oral discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Rectal tenesmus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Tongue ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Tooth disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Varices oesophageal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Asymptomatic COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Cytomegalovirus infection reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pneumocystis jirovecii pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Bacterial diarrhoea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Cellulitis of male external genital organ | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Conjunctivitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Cytomegalovirus gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Cytomegalovirus viraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Enterococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Gastrointestinal infection | 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 |
| Nail infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Oesophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Oral viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pneumonia klebsiella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Rhinovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Sinusitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Vestibular neuronitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Vulvovaginal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General 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 |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Cyst | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Drug intolerance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Hyperthermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Injection site rash | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Granuloma annulare | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Dermatitis psoriasiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Hand dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Intertrigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Onychoclasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Perivascular dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Precancerous skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Seborrhoeic dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Skin depigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Skin discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| ALT increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| AST increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood lactate dehydrogenase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Cytomegalovirus test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Lymphocyte count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| AST/ALT ratio abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Aspartate aminotransferase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood creatinine decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood immunoglobulin G decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Electrocardiogram QT prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Oxygen saturation decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Prothrombin time shortened | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| SARS-CoV-2 test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Troponin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Vitamin D decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system 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 |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Febrile bone marrow aplasia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Increased tendency to bruise | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 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 |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Appetite disorder | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Glucose tolerance impaired | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Tumour lysis syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Iron deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Overweight | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal 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 |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Catarrh | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Sinus disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Sputum discoloured | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Tachypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Upper respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Taste disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Monoparesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Post herpetic neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Toxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system 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 |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Arthropathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Inguinal mass | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Joint swelling | 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 |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Neck mass | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Glycosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Urinary tract disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (23.1) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Aortic valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Cardiomegaly | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Hyperdynamic left ventricle | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Hypertensive cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Ventricular arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (23.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| Affect lability | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| Nightmare | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Eye injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Vaccination complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.1) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.1) | View |
| Raynaud's phenomenon | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.1) | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.1) | View |
| Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (23.1) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Hepatocellular injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Seborrhoeic keratosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Haemangioma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Neoplasm swelling | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Squamous cell carcinoma of the tongue | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Tumour necrosis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Tumour pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | View |
| Hypoacusis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.1) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.1) | View |
| Deafness neurosensory | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.1) | View |
| Ear pruritus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.1) | View |
| Otolithiasis | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.1) | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.1) | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Blepharitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Eye haematoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Eye haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Punctate keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Oedema genital | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Pelvic discomfort | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Prostatomegaly | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Scrotal oedema | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (23.1) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (23.1) | View |
| Allergy to arthropod sting | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (23.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (23.1) | View |
| Ichthyosis | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (23.1) | View |
| Device failure | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (23.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Carpal tunnel syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Central nervous system lesion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (23.1) | View |