Time Frame |
2 years, 6 months
|
Adverse Event Reporting Description |
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Only patients who received at least a portion of a dose of TRC105 and/or Axitinib have been included in the analysis population.
|
|
Arm/Group Title
|
P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID
|
P2 Arm A: 5 mg Axitinib BID
|
P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
Arm/Group Description |
Phase 1b Dose Level 1: 8 mg/kg TRC1...
|
Phase 1b Dose Level 2: 10 mg/kg TRC...
|
Phase 1b Dose Level 3: 10 mg/kg TRC...
|
Phase 2 Arm A: 5 mg Axitinib twice ...
|
Phase 2 Arm B: 10 mg/kg TRC105 week...
|
Arm/Group Description |
Phase 1b Dose Level 1: 8 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
|
Phase 1b Dose Level 2: 10 mg/kg TRC105 weekly in combination with 5 mg Axitinib twice daily
|
Phase 1b Dose Level 3: 10 mg/kg TRC105 weekly during cycle 1 then 15 mg/kg TRC105 every two weeks beginning in cycle 2 in combination with 5 mg Axitinib twice daily
|
Phase 2 Arm A: 5 mg Axitinib twice daily
|
Phase 2 Arm B: 10 mg/kg TRC105 weekly + 5 mg Axitinib twice daily
|
|
|
P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID
|
P2 Arm A: 5 mg Axitinib BID
|
P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
6/73 (8.22%)
|
|
|
|
P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID
|
P2 Arm A: 5 mg Axitinib BID
|
P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
1/3 (33.33%)
|
|
4/15 (26.67%)
|
|
3/5 (60.00%)
|
|
27/74 (36.49%)
|
|
28/73 (38.36%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
Anaemia |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
5/73 (6.85%)
|
8 |
Cardiac disorders |
|
|
|
|
|
Acute Heart Failure |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Myocardial Infarction |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
2/74 (2.70%)
|
2 |
1/73 (1.37%)
|
1 |
Eye disorders |
|
|
|
|
|
Retinal Vein Occlusion |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Gastrointestinal disorders |
|
|
|
|
|
Abdominal Pain |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
1/5 (20.00%)
|
|
2/74 (2.70%)
|
3 |
0/73 (0.00%)
|
0 |
Gallbladder Perforation |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Colitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
0/74 (0.00%)
|
0 |
0/73 (0.00%)
|
0 |
Diarrhoea |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Oesophageal Ulcer Haemorrhage |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Colonic Perforation |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Gastrointestinal Perforation |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Gastrointestinal Haemorrhage |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
2/74 (2.70%)
|
2 |
1/73 (1.37%)
|
1 |
Lower Gastrointestinal Haemorrhage |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Pancreatitis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Pyrexia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
General disorders |
|
|
|
|
|
Chest Pain |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
2/74 (2.70%)
|
2 |
0/73 (0.00%)
|
0 |
Disease Progression |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
0 |
4/73 (5.48%)
|
4 |
Fatigue |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Fever |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
0 |
0/73 (0.00%)
|
0 |
Multi-organ Failure |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
0 |
0/73 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
|
|
Liver Injury |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Cholecystitis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
Biliary Tract Infection |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Clostridium Difficile Infection |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Clostridium Difficile Colitis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Enterococcal Infection |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Pneumonia |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Meningitis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Sepsis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
2/74 (2.70%)
|
2 |
1/73 (1.37%)
|
1 |
Injury, poisoning and procedural complications |
|
|
|
|
|
Infusion Related Reaction |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
0 |
0/73 (0.00%)
|
0 |
Femur Fracture |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Spinal Fracture |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
|
Dehydration |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
2/5 (40.00%)
|
|
0/74 (0.00%)
|
0 |
3/73 (4.11%)
|
3 |
Hyperkalaemia |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Hypoglycaemia |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Hypokalaemia |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Hyponatraemia |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
Back Pain |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
2/73 (2.74%)
|
2 |
Osteoarthritis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Muscular Weakness |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
Bronchial Neoplasm |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
Encephalopathy |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
2/73 (2.74%)
|
2 |
Epilepsy |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Hemiparesis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Haemorrhage Intracranial |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Migraine |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Paraparesis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Posterior Reversible Encephalopothy Syndrome |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Seizure |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Headache |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Psychiatric disorders |
|
|
|
|
|
Confusional State |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Renal and urinary disorders |
|
|
|
|
|
Acute Kidney Injury |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
2/73 (2.74%)
|
3 |
Reproductive system and breast disorders |
|
|
|
|
|
Pelvic Pain |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
Pulmonary Embolism |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
2/73 (2.74%)
|
2 |
Pulmonary Haemorrhage |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
0 |
0/73 (0.00%)
|
0 |
Dyspnoea |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Epistaxis |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Hypoxia |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Pleural Effusion |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
1/73 (1.37%)
|
1 |
Pneumothroax |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Pulmonary Embolism |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
1/73 (1.37%)
|
1 |
Respiratory Failure |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
0/74 (0.00%)
|
0 |
1/73 (1.37%)
|
1 |
Vomiting |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
1/73 (1.37%)
|
1 |
Vascular disorders |
|
|
|
|
|
Deep Vein Thrombosis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
0 |
0/73 (0.00%)
|
0 |
Hypertension |
0/3 (0.00%)
|
0 |
0/15 (0.00%)
|
0 |
0/5 (0.00%)
|
0 |
1/74 (1.35%)
|
1 |
0/73 (0.00%)
|
0 |
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
P1b: 8 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
P1b: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
P1b: 10 mg/kg Wkly/15 mg/kg q2wks TRC105 + 5 mg Axitinib BID
|
P2 Arm A: 5 mg Axitinib BID
|
P2 Arm B: 10 mg/kg TRC105 Wkly + 5 mg Axitinib BID
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
3/3 (100.00%)
|
|
15/15 (100.00%)
|
|
5/5 (100.00%)
|
|
71/74 (95.95%)
|
|
72/73 (98.63%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
Anaemia |
1/3 (33.33%)
|
|
4/15 (26.67%)
|
|
1/5 (20.00%)
|
|
12/74 (16.22%)
|
|
16/73 (21.92%)
|
|
Leukocytosis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Leukopenia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Microcytic Anaemia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Neutropenia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Polycythaemia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
1/73 (1.37%)
|
|
Thrombocytosis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
3/73 (4.11%)
|
|
Haemolytic anaemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Cardiac disorders |
|
|
|
|
|
Acute Coronary Syndrome |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Angina Pectoris |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Arrhythmia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Brachycardia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
0/73 (0.00%)
|
|
Bundle Branch Block Right |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Cardiac Disorder |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Cardiac Failure |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Cardiac Failure Acute |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Coronary Artery Disease |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Coronary Artery Thrombosis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Diastolic Dysfunction |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Left Ventricular Dysfunction |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Mitral Valve Incompetence |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Pericardial Effusion |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Sinus Bradycardia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Sinus Tachycardia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
1/73 (1.37%)
|
|
Supraventricular Extrasystoles |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Tachycardia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
1/5 (20.00%)
|
|
1/74 (1.35%)
|
|
5/73 (6.85%)
|
|
Tricuspid Valve Incompetence |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Ventricular Extrasystoles |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
3/73 (4.11%)
|
|
Wandering Pacemaker |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Palpitations |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Ear and labyrinth disorders |
|
|
|
|
|
Cerumen Impaction |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Ear Discomfort |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Ear Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
3/73 (4.11%)
|
|
Hearing Impaired |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
2/73 (2.74%)
|
|
Hypoacusis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Tinnitus |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
3/73 (4.11%)
|
|
Tympanic Membrane Perforation |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Vertigo |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Ear Haemorrhage |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Endocrine disorders |
|
|
|
|
|
Adrenal Insufficiency |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Hypercalcaemia of malignancy |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Hyperthyroidism |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Hypothyroidism |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
20/74 (27.03%)
|
|
17/73 (23.29%)
|
|
Thyroid Disorder |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Eye disorders |
|
|
|
|
|
Cataract |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Dry Eye |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Eye Discharge |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Eye Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Lacrimation increased |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Periorbital Oedema |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Photophobia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Retinal Vein Occlusion |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Vision Blurred |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
2/73 (2.74%)
|
|
Visual Impairment |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Ocular Hyperaemia |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Gastrointestinal disorders |
|
|
|
|
|
Abdominal Discomfort |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Abdominal Distension |
0/3 (0.00%)
|
|
3/15 (20.00%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
1/73 (1.37%)
|
|
Abdominal Hernia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Abdominal Pain |
0/3 (0.00%)
|
|
5/15 (33.33%)
|
|
1/5 (20.00%)
|
|
2/74 (2.70%)
|
|
10/73 (13.70%)
|
|
Abdominal Pain Lower |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Abdominal Pain Upper |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
5/74 (6.76%)
|
|
11/73 (15.07%)
|
|
Abdominal Tenderness |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Anorectal Discomfort |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Ascites |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Cheilitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Colitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Constipation |
1/3 (33.33%)
|
|
5/15 (33.33%)
|
|
2/5 (40.00%)
|
|
13/74 (17.57%)
|
|
21/73 (28.77%)
|
|
Dental Caries |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
3/73 (4.11%)
|
|
Diarrhoea |
3/3 (100.00%)
|
|
11/15 (73.33%)
|
|
4/5 (80.00%)
|
|
46/74 (62.16%)
|
|
42/73 (57.53%)
|
|
Diverticulum |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Dry Mouth |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
7/74 (9.46%)
|
|
7/73 (9.59%)
|
|
Dyskinesia Oesophageal |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Dyspepsia |
1/3 (33.33%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
10/74 (13.51%)
|
|
6/73 (8.22%)
|
|
Dysphagia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
2/73 (2.74%)
|
|
Enteritis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Faecal Incontinence |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Faeces Discoloured |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Faeces Pale |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Flatulence |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
7/73 (9.59%)
|
|
Gastritis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
1/73 (1.37%)
|
|
Gastrointestinal Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Gastrooesophageal Reflux Disease |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
3/73 (4.11%)
|
|
Gingival Bleeding |
2/3 (66.67%)
|
|
7/15 (46.67%)
|
|
5/5 (100.00%)
|
|
3/74 (4.05%)
|
|
25/73 (34.25%)
|
|
Gingival Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
4/73 (5.48%)
|
|
Glossitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Glossodynia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Haematemesis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Haematochezia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
2/73 (2.74%)
|
|
Haemorrhoidal Haemorrhage |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Haemorrhoids |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
4/73 (5.48%)
|
|
Hiatus Hernia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Large Intestine Perforation |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Melaena |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Mesenteric Vein Thrombosis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Mouth Haemorrhage |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Mouth Ulceration |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Nausea |
1/3 (33.33%)
|
|
9/15 (60.00%)
|
|
4/5 (80.00%)
|
|
27/74 (36.49%)
|
|
38/73 (52.05%)
|
|
Oesophageal Ulcer |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Oesophagitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Oral Discomfort |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Oral Disorder |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Oral Dysaesthesia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Oral Mucosal Erythema |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Oral Pain |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
8/73 (10.96%)
|
|
Paraesthesia Oral |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Peptic Ulcer |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Periodontal Disease |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Proctalgia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Rectal Haemorrhage |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
3/73 (4.11%)
|
|
Retching |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Salivary Hypersecretion |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Stomatitis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
3/5 (60.00%)
|
|
8/74 (10.81%)
|
|
18/73 (24.66%)
|
|
Swollen Tongue |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Toothache |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
0/73 (0.00%)
|
|
Vomiting |
1/3 (33.33%)
|
|
5/15 (33.33%)
|
|
4/5 (80.00%)
|
|
14/74 (18.92%)
|
|
30/73 (41.10%)
|
|
Duodenditis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Impaired Gastric Emptying |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Periodontitis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
General disorders |
|
|
|
|
|
Asthenia |
3/3 (100.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
9/74 (12.16%)
|
|
6/73 (8.22%)
|
|
Catheter Site Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Catheter Site Swelling |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Chest Discomfort |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Chest Pain |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
1/73 (1.37%)
|
|
Chills |
3/3 (100.00%)
|
|
1/15 (6.67%)
|
|
1/5 (20.00%)
|
|
7/74 (9.46%)
|
|
11/73 (15.07%)
|
|
Drug Intolerance |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Facial Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Fatigue |
3/3 (100.00%)
|
|
9/15 (60.00%)
|
|
4/5 (80.00%)
|
|
40/74 (54.05%)
|
|
42/73 (57.53%)
|
|
Feeling Cold |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Feeling Hot |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
General Physical Health Deterioration |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Influenza Like Illness |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
2/73 (2.74%)
|
|
Infusion Site Erythema |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Infusion Site Extravasation |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Injection Site Erythema |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Injection Site Haemorrhage |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Injection Site Mass |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Local Swelling |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Malaise |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
4/74 (5.41%)
|
|
3/73 (4.11%)
|
|
Medical Device Site Bruise |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Mucosal Inflammation |
1/3 (33.33%)
|
|
7/15 (46.67%)
|
|
0/5 (0.00%)
|
|
6/74 (8.11%)
|
|
10/73 (13.70%)
|
|
Non-Cardiac Chest Pain |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
3/73 (4.11%)
|
|
Oedema |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Oedema Peripheral |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
5/74 (6.76%)
|
|
5/73 (6.85%)
|
|
Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
2/73 (2.74%)
|
|
Pyrexia |
2/3 (66.67%)
|
|
4/15 (26.67%)
|
|
1/5 (20.00%)
|
|
4/74 (5.41%)
|
|
10/73 (13.70%)
|
|
Temperature Intolerance |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Thirst |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Gait Disturbance |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Hepatobiliary disorders |
|
|
|
|
|
Bile Duct Stenosis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Cholelithiasis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Gallbladder Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Hepatitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Liver Disorder |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Immune system disorders |
|
|
|
|
|
Hypersensitivity |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Seasonal Allergy |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Infections and infestations |
|
|
|
|
|
Anal Abscess |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Bronchitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Candidiasis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
1/5 (20.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Cellulitis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Cystitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
3/73 (4.11%)
|
|
Dacryocanaliculitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Diarrhoea Infectious |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Folliculitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Fungal Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Fungal Skin Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Furuncle |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Gingival Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Incision Site Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Influenza |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Kidney Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Lung Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Lymph Gland Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Nail Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Nasopharyngitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
3/73 (4.11%)
|
|
Oral Candidiasis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Oral Herpes |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
4/73 (5.48%)
|
|
Otitis Externa |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Otitis Media |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Paronychia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Pharyngitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Platelet Count Decreased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Pneumonia |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
3/73 (4.11%)
|
|
Sepsis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Sinusitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
6/74 (8.11%)
|
|
3/73 (4.11%)
|
|
Skin Infection |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Staphylococcal Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Tinea Cruris |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Tinea Pedis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Tinea Versicolour |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Tooth Abscess |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
3/73 (4.11%)
|
|
Tooth Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
1/73 (1.37%)
|
|
Upper Respiratory Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
8/74 (10.81%)
|
|
6/73 (8.22%)
|
|
Upper Respiratory Tract Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Urinary Tract Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
3/5 (60.00%)
|
|
4/74 (5.41%)
|
|
5/73 (6.85%)
|
|
Vaginal Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Viral Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Vulvovaginal Mycotic Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Wound Infection |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Nasal Vestibulitis |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Pneumonial Staphylococcal |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Injury, poisoning and procedural complications |
|
|
|
|
|
Contusion |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Fall |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
4/73 (5.48%)
|
|
Head Injury |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Incisional Hernia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Infusion Related Reaction |
0/3 (0.00%)
|
|
3/15 (20.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
19/73 (26.03%)
|
|
Joint Injury |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Laceration |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Limb Injury |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Lower Limb Fracture |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Muscle Strain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Post Procedural Discomfort |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Procedural pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Rib Fracture |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Road Traffic Accident |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Skin Abrasion |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Sternal Fracture |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Thermal Burn |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Wound |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Wound Complication |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Wound Dehiscence |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Investigations |
|
|
|
|
|
Activated Partial Thromboplastin Time Prolonged |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Alanine Aminotransferase Increased |
1/3 (33.33%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
4/73 (5.48%)
|
|
Aspartate Aminotransferase Increased |
1/3 (33.33%)
|
|
3/15 (20.00%)
|
|
0/5 (0.00%)
|
|
7/74 (9.46%)
|
|
5/73 (6.85%)
|
|
Blood Alkaline Phosphatase Increased |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
7/73 (9.59%)
|
|
Blood Amylase Increased |
1/3 (33.33%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
7/74 (9.46%)
|
|
2/73 (2.74%)
|
|
Blood Bilirubin Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Blood Creatinine Increased |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
9/74 (12.16%)
|
|
5/73 (6.85%)
|
|
Blood Pressure Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
1/73 (1.37%)
|
|
Blood Thyroid Stimulating Hormone Decreased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Blood Thyroid Stimulating Hormone Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
5/73 (6.85%)
|
|
Blood Urea Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Cardiac Murmur |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Electrocardiogram QT Prolonged |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
3/73 (4.11%)
|
|
Epidermal Growth Factor Receptor Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Gamma-Glutamyltransferase Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Glucose Urine Present |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Haemoglobin Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
International Normalised Ratio Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Iron Binding Capacity Total Decreased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Lipase Increased |
1/3 (33.33%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
5/74 (6.76%)
|
|
2/73 (2.74%)
|
|
Liver Function Test Abnormal |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Liver Function Test Increased |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Lymphocyte Count Decreased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Mycobacterium Tuberculosis Complex Test Positive |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Red Blood Cells Urine |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Transaminases Increased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Vitamin D Decreased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Weight Decreased |
0/3 (0.00%)
|
|
3/15 (20.00%)
|
|
2/5 (40.00%)
|
|
17/74 (22.97%)
|
|
27/73 (36.99%)
|
|
Weight Increased |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
White Blood Cell Count Decreased |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
White Blood Cells Urine |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Metabolism and nutrition disorders |
|
|
|
|
|
Cachexia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Decreased Appetite |
3/3 (100.00%)
|
|
5/15 (33.33%)
|
|
3/5 (60.00%)
|
|
26/74 (35.14%)
|
|
21/73 (28.77%)
|
|
Dehydration |
3/3 (100.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
7/74 (9.46%)
|
|
11/73 (15.07%)
|
|
Food Intolerance |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Glucose Tolerance Impaired |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Gout |
2/3 (66.67%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
1/73 (1.37%)
|
|
Hypercalcaemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
5/74 (6.76%)
|
|
2/73 (2.74%)
|
|
Hypercholesterolaemia |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Hyperglycaemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
6/74 (8.11%)
|
|
5/73 (6.85%)
|
|
Hyperkalaemia |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
2/73 (2.74%)
|
|
Hypernatraemia |
0/3 (0.00%)
|
|
3/15 (20.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Hyperuricaemia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Hypoalbuminaemia |
1/3 (33.33%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
5/73 (6.85%)
|
|
Hypocalcaemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
2/73 (2.74%)
|
|
Hypoglycaemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Hypokalaemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
3/73 (4.11%)
|
|
Hypomagnesaemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
1/5 (20.00%)
|
|
2/74 (2.70%)
|
|
2/73 (2.74%)
|
|
Hyponatraemia |
1/3 (33.33%)
|
|
2/15 (13.33%)
|
|
1/5 (20.00%)
|
|
5/74 (6.76%)
|
|
12/73 (16.44%)
|
|
Hypophosphataemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
1/5 (20.00%)
|
|
6/74 (8.11%)
|
|
3/73 (4.11%)
|
|
Hypoproteinaemia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Hypovolaemia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Type 2 Diabetes Mellitus |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Hyperphosphataemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Hypertriglyceridaemia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
Arthralgia |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
10/74 (13.51%)
|
|
8/73 (10.96%)
|
|
Back Pain |
0/3 (0.00%)
|
|
3/15 (20.00%)
|
|
1/5 (20.00%)
|
|
17/74 (22.97%)
|
|
7/73 (9.59%)
|
|
Bone Pain |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
3/73 (4.11%)
|
|
Flank Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
5/73 (6.85%)
|
|
Groin Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
1/73 (1.37%)
|
|
Inguinal Mass |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Joint Swelling |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Muscle Spasms |
0/3 (0.00%)
|
|
2/15 (13.33%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
2/73 (2.74%)
|
|
Muscular Weakness |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
4/73 (5.48%)
|
|
Musculoskeletal Chest Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
5/74 (6.76%)
|
|
3/73 (4.11%)
|
|
Musculoskeletal Pain |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
6/74 (8.11%)
|
|
5/73 (6.85%)
|
|
Myalgia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
5/74 (6.76%)
|
|
7/73 (9.59%)
|
|
Neck Pain |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
4/74 (5.41%)
|
|
2/73 (2.74%)
|
|
Osteoarthritis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Osteoporosis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Pain In Extremity |
0/3 (0.00%)
|
|
5/15 (33.33%)
|
|
0/5 (0.00%)
|
|
6/74 (8.11%)
|
|
14/73 (19.18%)
|
|
Pain In Jaw |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Pathological Fracture |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Plantar Fasciitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
1/73 (1.37%)
|
|
Spondylolisthesis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Tendonitis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Musculoskeletal Stiffness |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
0/73 (0.00%)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
Basal Cell Carcinoma |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
3/73 (4.11%)
|
|
Benign Neoplasm |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Breast Cancer |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Skin Papilloma |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Nervous system disorders |
|
|
|
|
|
Amnesia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Balance Disorder |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Burning Sensation |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Cerebrovascular Accident |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Cognitive Disorder |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Convulsion |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Disturbance In Attention |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Dizziness |
1/3 (33.33%)
|
|
3/15 (20.00%)
|
|
1/5 (20.00%)
|
|
9/74 (12.16%)
|
|
10/73 (13.70%)
|
|
Dizziness Postural |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Dysaesthesia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Dysgeusia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
1/5 (20.00%)
|
|
9/74 (12.16%)
|
|
10/73 (13.70%)
|
|
Dyskinesia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Encephalopathy |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Headache |
3/3 (100.00%)
|
|
10/15 (66.67%)
|
|
2/5 (40.00%)
|
|
12/74 (16.22%)
|
|
47/73 (64.38%)
|
|
Hyperaesthesia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Hypersomnia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Hypoaesthesia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Hypotonia |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Lethargy |
2/3 (66.67%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Memory Impairment |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
2/73 (2.74%)
|
|
Mental Impairment |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Metabolic Encephalopathy |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
1/73 (1.37%)
|
|
Migraine |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
0/74 (0.00%)
|
|
5/73 (6.85%)
|
|
Neuropathy Peripheral |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
0/73 (0.00%)
|
|
Paraesthesia |
0/3 (0.00%)
|
|
1/15 (6.67%)
|
|
0/5 (0.00%)
|
|
3/74 (4.05%)
|
|
2/73 (2.74%)
|
|
Paresis |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
1/74 (1.35%)
|
|
0/73 (0.00%)
|
|
Peripheral Sensory Neuropathy |
0/3 (0.00%)
|
|
0/15 (0.00%)
|
|
0/5 (0.00%)
|
|
2/74 (2.70%)
|
|
1/73 (1.37%)
|