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 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
NCT ID:
NCT01663727
Description:
Safety population: All randomized participants who received at least one full or partial dose of any component of the study treatment (bevacizumab, placebo, or paclitaxel).
Frequency Threshold:
5
Time Frame:
From the first dose of study drug through 30 days after the last dose of study drug or clinical cut-off (up to 115.1 weeks)
Study:
NCT01663727
Study Brief:
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast 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 |
|---|---|---|---|---|---|---|---|---|
| Paclitaxel+Placebo | Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death. | 162 | None | 45 | 233 | 225 | 233 | View |
| Paclitaxel+ Bevacizumab | Participants received paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death. | 161 | None | 66 | 238 | 230 | 238 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abscess limb | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Cholecystitis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Colonic abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Device related sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Lung infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Pharyngotonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Pneumonia necrotising | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Sepsis syndrome | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Wound infection bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| Urine output decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Type 2 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Osteonecrosis of jaw | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Cancer pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Gastric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | View |
| Cerebral ischaemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Dementia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Speech disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Spinal cord compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Cystitis haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.1) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.1) | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Pain of skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Skin haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Aortic stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| Embolism venous | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| Superior vena cava syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| Venous thrombosis limb | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| ACUTE CORONARY SYNDROME | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| CARDIAC FAILURE CONGESTIVE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| CATARACT | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| CATHETER SITE ERYTHEMA | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| ANAPHYLACTIC REACTION | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.1) | View |
| VIRAL INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| CATHETER SITE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| KLEBSIELLA SEPSIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| SOFT TISSUE INFECTION | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| URINARY TRACT INFECTION BACTERIAL | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| ROAD TRAFFIC ACCIDENT | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| STERNAL FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| WOUND DEHISCENCE | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.1) | View |
| HYPOKALAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| HYPONATRAEMIA | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| LACTIC ACIDOSIS | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| ARTERIAL THROMBOSIS | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Duodenal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Gastric ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Gastric varices haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Sudden death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Bile duct obstruction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (17.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| Left ventricular dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Optic nerve disorder | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Visual acuity reduced | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.1) | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (17.1) | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (17.1) | View |
| Gallbladder pain | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (17.1) | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (17.1) | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (17.1) | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (17.1) | View |
| Abdominal wall abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.1) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (17.1) | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Nail discolouration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Nail disorder | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Onychomadesis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Pruritis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.1) | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.1) | View |
| SINUSITIS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| WEIGHT DECREASED | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| NECK PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| MUSCULOSKELETAL PAIN | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.1) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | View |