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 @ 3:05 AM
Ignite Modification Date:
2025-12-26 @ 1:44 AM
NCT ID:
NCT00809133
Description:
None
Frequency Threshold:
5
Time Frame:
From first drug administration until 21 days (part C and D) or 28 days (part A and B) after the last trial drug administration in the last treatment cycle, up to 1184 days.
Study:
NCT00809133
Study Brief:
Trial Exploring Afatinib (BIBW 2992) + Paclitaxel (Part A), Afatinib + Paclitaxel + Bevacizumab (Part B), Afatinib + Carboplatin (Part C) and Afatinib+ Paclitaxel +Carboplatin(Part D) in Patients With Advanced Solid Tumours
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part A: A20P80 (Afatinib + Paclitaxel) | Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle. | None | None | 2 | 3 | 3 | 3 | View |
| Part A: A40P80 (Afatinib + Paclitaxel) | Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle. | None | None | 5 | 7 | 7 | 7 | View |
| Part A: A50P80 (Afatinib + Paclitaxel) | Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle. | None | None | 3 | 6 | 6 | 6 | View |
| Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin) | Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle. | None | None | 4 | 5 | 5 | 5 | View |
| Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab) | Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle. | None | None | 1 | 3 | 3 | 3 | View |
| Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab) | Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle. | None | None | 4 | 5 | 5 | 5 | View |
| Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab) | Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle. | None | None | 5 | 7 | 7 | 7 | View |
| Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab) | Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle. | None | None | 6 | 6 | 6 | 6 | View |
| Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab) | Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle. | None | None | 5 | 8 | 8 | 8 | View |
| Part C: A20C6 (Afatinib + Carboplatin) | Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle. | None | None | 3 | 3 | 3 | 3 | View |
| Part C: A40C6 (Afatinib + Carboplatin) | Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle. | None | None | 3 | 9 | 9 | 9 | View |
| Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin) | Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle. | None | None | 3 | 6 | 6 | 6 | View |
| Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin) | Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle. | None | None | 5 | 8 | 8 | 8 | View |
| Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin) | Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle. | None | None | 4 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Diarrhoea haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Small intestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Bile duct obstruction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 18.0 | View |
| Catheter site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Device related sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Escherichia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| H1N1 influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Lymphangitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Mycobacterial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pneumonia streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Respiratory tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Vascular pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Cervix cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Non-small cell lung cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Oesophageal cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Pericardial effusion malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Tumour haemorrhage | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Dystonia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Facial paresis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Neurological decompensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Partial seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pneumothorax spontaneous | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Axillary vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Early satiety | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Infusion site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Tenderness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Thrombosis in device | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Ulcer | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.0 | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.0 | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 18.0 | View |
| Bacteriuria | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Blister infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Catheter site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Pruritus generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Rash papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Rosacea | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Scab | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Skin fissures | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Skin reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Telangiectasia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Flushing | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.0 | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Microcytic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Lip dry | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Lip pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Catheter site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Catheter site inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Catheter site swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Lymphangitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Nail infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Omphalitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Hypermagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Bone swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Chest wall mass | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Clubbing | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Brachial plexopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Hyperaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Peroneal nerve palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Sensory disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Speech disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Bladder obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Polyuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Galactostasis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Vulvovaginal discomfort | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 18.0 | View |
| Choking sensation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Sputum discoloured | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Sputum increased | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Cold sweat | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Intertrigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Nail discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Nail pitting | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Onycholysis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Pain of skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.0 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Blood thyroid stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 18.0 | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.0 | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.0 | View |
| Ear haemorrhage | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.0 | View |
| Episcleritis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Eye discharge | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 18.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Cheilitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Gastrointestinal motility disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Gingival pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Glossodynia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Odynophagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Tongue discolouration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Tongue ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Tooth disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.0 | View |
| Suprapubic pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Genital abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Genital herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| H1N1 influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Klebsiella infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Labyrinthitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Laryngitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Infusion related reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Alanine aminotransferase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Blood calcium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Blood sodium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.0 | View |
| Limb discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Musculoskeletal discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Myositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Spinal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | View |
| Ageusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.0 | View |
| Micturition urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 18.0 | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Dyspnoea exertional | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Nasal dryness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Nasal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Nasal obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pharyngeal erythema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |
| Rhinalgia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | View |