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 @ 6:45 PM
Ignite Modification Date:
2025-12-25 @ 4:16 PM
NCT ID:
NCT01461057
Description:
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
Frequency Threshold:
5
Time Frame:
From randomization of first participant to end of study (approximately 6 years)
Study:
NCT01461057
Study Brief:
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric 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 |
|---|---|---|---|---|---|---|---|---|
| Pertuzumab 840/420 mg | Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m\^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m\^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. | 10 | None | 11 | 15 | 15 | 15 | View |
| Pertuzumab 840/840 mg | Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m\^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m\^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles. | 9 | None | 10 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA 20.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 20.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Gastric haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Obstruction gastric | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | medDRA 20.1 | View |
| Biliary sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Biliary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Pneumonia fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | medDRA 20.1 | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Myoglobin blood increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Food intolerance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA 20.1 | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA 20.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA 20.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA 20.1 | View |
| Neutrophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA 20.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | medDRA 20.1 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | medDRA 20.1 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | medDRA 20.1 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | medDRA 20.1 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | medDRA 20.1 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | medDRA 20.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Eructation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Gastrointestinal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Stomatits | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Tooth loss | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | medDRA 20.1 | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Face oedema | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Injection site reaction | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Xerosis | SYSTEMATIC_ASSESSMENT | General disorders | medDRA 20.1 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | medDRA 20.1 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | medDRA 20.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Hepatitis B | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Herpes Simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Tinea versicolour | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Toxocariasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | medDRA 20.1 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | medDRA 20.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | medDRA 20.1 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Aspartate aminotransferase inreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Bilirubin conjugated increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood cholinesterase decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood creatine phosphokinase MB increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood fibrinogen increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood iron increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Creatinine renal clearance decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Fibrin D dimer increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Glomerular filtration rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Protein total decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Prothrombin time shortened | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hypochloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hyposideraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hypovitaminosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 20.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 20.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 20.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 20.1 | View |
| Ageusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Cholinergic syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Neurotoxicity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Tension headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | medDRA 20.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 20.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 20.1 | View |
| Somatic symptom disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 20.1 | View |
| Acute prerenal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | medDRA 20.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Rales | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Nail ridging | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Onychomadesis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Skin hyperpigmentation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Stasis dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 20.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 20.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 20.1 | View |
| Subclavian vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 20.1 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | medDRA 20.1 | View |
| Urine output decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Vitamin D decreased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Nasal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | medDRA 20.1 | View |
| Hyperphosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |
| Fracture pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 20.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | medDRA 20.1 | View |
| Affective disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 20.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | medDRA 20.1 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | medDRA 20.1 | View |
| Onycholysis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | medDRA 20.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 20.1 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 20.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | medDRA 20.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | medDRA 20.1 | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | medDRA 20.1 | View |
| Allergic transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | medDRA 20.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | medDRA 20.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | medDRA 20.1 | View |