Time Frame |
Adverse events (and serious adverse events) were recorded from the time the participant received the first dose of study drug up to 30 days after the last dose, up to approximately 30 months postdose.
|
Adverse Event Reporting Description |
[Not Specified]
|
|
Arm/Group Title
|
Dose Escalation Cohort 1: 200 mg QD
|
Dose Escalation Cohort 2: 300 mg QD
|
Dose Escalation Cohort 3: 400 mg QD
|
Dose Escalation Cohort 4: 600 mg QD
|
Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)
|
Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)
|
Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)
|
MEC Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
GIST Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
ATC Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Malignant Effusion Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Other Solid Tumor Type Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Arm/Group Description |
Participants with advanced, incurab...
|
Participants with advanced, incurab...
|
Participants with advanced, incurab...
|
Participants with advanced, incurab...
|
Participants with advanced, incurab...
|
Participants with advanced, incurab...
|
Participants with advanced, incurab...
|
Participants with advanced or recur...
|
Participants with advanced pigmente...
|
Participants with advanced gastroin...
|
Participants with anaplastic thyroi...
|
Participants with advanced solid tu...
|
Participants with other solid tumor...
|
Arm/Group Description |
Participants with advanced, incurable, solid tumors who received PLX3397 200 mg QD.
|
Participants with advanced, incurable, solid tumors who received PLX3397 300 mg QD.
|
Participants with advanced, incurable, solid tumors who received PLX3397 400 mg QD.
|
Participants with advanced, incurable, solid tumors who received PLX3397 600 mg QD.
|
Participants with advanced, incurable, solid tumors who received PLX3397 900 mg/day.
|
Participants with advanced, incurable, solid tumors who received PLX3397 1200 mg/day.
|
Participants with advanced, incurable, solid tumors who received PLX3397 1000 mg/day.
|
Participants with advanced or recurrent mucoepidermoid carcinoma (MEC) who received PLX3397.
|
Participants with advanced pigmented villonodular synovitis (PVNS) who received PLX3397.
|
Participants with advanced gastrointestinal stromal tumor (GIST) who received PLX3397.
|
Participants with anaplastic thyroid carcinoma (ATC) who received PLX3397.
|
Participants with advanced solid tumors with malignant effusion who received PLX3397.
|
Participants with other solid tumor types who received PLX3397.
|
|
|
Dose Escalation Cohort 1: 200 mg QD
|
Dose Escalation Cohort 2: 300 mg QD
|
Dose Escalation Cohort 3: 400 mg QD
|
Dose Escalation Cohort 4: 600 mg QD
|
Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)
|
Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)
|
Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)
|
MEC Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
GIST Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
ATC Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Malignant Effusion Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Other Solid Tumor Type Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
0/3 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
3/11 (27.27%) |
1/9 (11.11%) |
1/8 (12.50%) |
1/20 (5.00%) |
|
|
Dose Escalation Cohort 1: 200 mg QD
|
Dose Escalation Cohort 2: 300 mg QD
|
Dose Escalation Cohort 3: 400 mg QD
|
Dose Escalation Cohort 4: 600 mg QD
|
Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)
|
Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)
|
Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)
|
MEC Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
GIST Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
ATC Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Malignant Effusion Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Other Solid Tumor Type Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
3/7 (42.86%) |
2/4 (50.00%) |
5/39 (12.82%) |
4/11 (36.36%) |
1/9 (11.11%) |
2/8 (25.00%) |
3/20 (15.00%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Febrile neutropenia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Ascites |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Haematochezia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Small intestinal obstruction |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Diarrhoea |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
General disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pyrexia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cholecystitis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hepatic haemorrhage |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pneumonia |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
2/20 (10.00%) |
Bacterial sepsis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Cellulitis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Clostridium difficile colitis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Sepsis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Upper respiratory tract infection |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Investigations |
|
|
|
|
|
|
|
|
|
|
|
|
|
Transaminases increased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dehydration |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
1/20 (5.00%) |
Hyponatraemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Hypoglycaemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypomagnesaemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Neck pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal cell carcinoma |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerebrovascular accident |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Dizziness |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental status changes |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal failure acute |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute respiratory failure |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypoxia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Pleural effusion |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deep vein thrombosis |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Term from vocabulary, MedDRA (12.1)
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Dose Escalation Cohort 1: 200 mg QD
|
Dose Escalation Cohort 2: 300 mg QD
|
Dose Escalation Cohort 3: 400 mg QD
|
Dose Escalation Cohort 4: 600 mg QD
|
Dose Escalation Cohort 5: 900 mg/Day (500mg AM, 400mg PM)
|
Dose Escalation Cohort 6: 1200 mg/Day (600mg BID)
|
Dose Escalation Cohort 7: 1000 mg/Day (500mg BID)
|
MEC Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
PVNS Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
GIST Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
ATC Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Malignant Effusion Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
Other Solid Tumor Type Cohort 1000 mg/Day (600mg AM, 400mg PM)
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
3/3 (100.00%) |
6/6 (100.00%) |
6/6 (100.00%) |
6/6 (100.00%) |
6/7 (85.71%) |
6/6 (100.00%) |
7/7 (100.00%) |
4/4 (100.00%) |
39/39 (100.00%) |
11/11 (100.00%) |
8/9 (88.89%) |
8/8 (100.00%) |
20/20 (100.00%) |
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaemia |
0/3 (0.00%) |
3/6 (50.00%) |
4/6 (66.67%) |
3/6 (50.00%) |
2/7 (28.57%) |
3/6 (50.00%) |
2/7 (28.57%) |
0/4 (0.00%) |
7/39 (17.95%) |
3/11 (27.27%) |
0/9 (0.00%) |
2/8 (25.00%) |
6/20 (30.00%) |
Neutropenia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
1/20 (5.00%) |
Thrombocytopenia |
0/3 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Leukocytosis |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Lymphadenopathy |
1/3 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Leukopenia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Lymphopenia |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Febrile neutropenia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Angina pectoris |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Tachycardia |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Palpitations |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
2/9 (22.22%) |
0/8 (0.00%) |
0/20 (0.00%) |
Electromechanical dissociation |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Sinus bradycardia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
0/20 (0.00%) |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Tinnitus |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Ear discomfort |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Endocrine disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypothyroidism |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Eye disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conjunctival haemorrhage |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
1/9 (11.11%) |
0/8 (0.00%) |
1/20 (5.00%) |
Eye discharge |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Orbital oedema |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Vision blurred |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
6/39 (15.38%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
2/20 (10.00%) |
Visual impairment |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Diplopia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
2/20 (10.00%) |
Eye irritation |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Eye pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Eye pruritus |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Myodesopsia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Dry eye |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Nausea |
1/3 (33.33%) |
3/6 (50.00%) |
3/6 (50.00%) |
4/6 (66.67%) |
4/7 (57.14%) |
2/6 (33.33%) |
2/7 (28.57%) |
1/4 (25.00%) |
26/39 (66.67%) |
4/11 (36.36%) |
3/9 (33.33%) |
5/8 (62.50%) |
9/20 (45.00%) |
Diarrhoea |
0/3 (0.00%) |
1/6 (16.67%) |
2/6 (33.33%) |
2/6 (33.33%) |
0/7 (0.00%) |
2/6 (33.33%) |
2/7 (28.57%) |
2/4 (50.00%) |
14/39 (35.90%) |
4/11 (36.36%) |
2/9 (22.22%) |
3/8 (37.50%) |
2/20 (10.00%) |
Vomiting |
1/3 (33.33%) |
3/6 (50.00%) |
2/6 (33.33%) |
3/6 (50.00%) |
3/7 (42.86%) |
1/6 (16.67%) |
3/7 (42.86%) |
1/4 (25.00%) |
12/39 (30.77%) |
1/11 (9.09%) |
3/9 (33.33%) |
2/8 (25.00%) |
7/20 (35.00%) |
Dry mouth |
0/3 (0.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
4/39 (10.26%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
2/20 (10.00%) |
Constipation |
0/3 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/6 (16.67%) |
3/7 (42.86%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
11/39 (28.21%) |
2/11 (18.18%) |
4/9 (44.44%) |
3/8 (37.50%) |
6/20 (30.00%) |
Abdominal pain upper |
1/3 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/6 (33.33%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
3/39 (7.69%) |
2/11 (18.18%) |
1/9 (11.11%) |
1/8 (12.50%) |
1/20 (5.00%) |
Abdominal distension |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/6 (33.33%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
3/39 (7.69%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Abdominal pain |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
2/39 (5.13%) |
4/11 (36.36%) |
0/9 (0.00%) |
0/8 (0.00%) |
2/20 (10.00%) |
Dyspepsia |
1/3 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/6 (33.33%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
5/39 (12.82%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Retching |
1/3 (33.33%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Ascites |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Stomatitis |
1/3 (33.33%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Abdominal discomfort |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Abdominal pain lower |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Aphthous stomatitis |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Eructation |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Faecal incontinence |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Flatulence |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Gastrooesophageal reflux disease |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
5/39 (12.82%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Gingival bleeding |
1/3 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Haematemesis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Oesophageal stenosis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Proctalgia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Rectal haemorrhage |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Toothache |
1/3 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Dysphagia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
2/9 (22.22%) |
0/8 (0.00%) |
1/20 (5.00%) |
Gingival pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Haematochezia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
2/20 (10.00%) |
Haemorrhoids |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Small intestine obstruction |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Tooth discolouration |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Upper gastrointestinal haemorrhage |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
General disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Fatigue |
0/3 (0.00%) |
3/6 (50.00%) |
1/6 (16.67%) |
3/6 (50.00%) |
5/7 (71.43%) |
2/6 (33.33%) |
3/7 (42.86%) |
2/4 (50.00%) |
36/39 (92.31%) |
7/11 (63.64%) |
5/9 (55.56%) |
6/8 (75.00%) |
12/20 (60.00%) |
Oedema peripheral |
1/3 (33.33%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
14/39 (35.90%) |
2/11 (18.18%) |
2/9 (22.22%) |
0/8 (0.00%) |
3/20 (15.00%) |
Face oedema |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/4 (0.00%) |
6/39 (15.38%) |
0/11 (0.00%) |
2/9 (22.22%) |
1/8 (12.50%) |
0/20 (0.00%) |
Mucosal inflammation |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
5/39 (12.82%) |
0/11 (0.00%) |
0/9 (0.00%) |
2/8 (25.00%) |
0/20 (0.00%) |
Swelling face |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Pyrexia |
0/3 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
2/6 (33.33%) |
0/7 (0.00%) |
2/6 (33.33%) |
1/7 (14.29%) |
0/4 (0.00%) |
2/39 (5.13%) |
1/11 (9.09%) |
1/9 (11.11%) |
1/8 (12.50%) |
2/20 (10.00%) |
Chest pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/4 (0.00%) |
2/39 (5.13%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Chills |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
2/11 (18.18%) |
1/9 (11.11%) |
0/8 (0.00%) |
1/20 (5.00%) |
Asthenia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
2/11 (18.18%) |
0/9 (0.00%) |
1/8 (12.50%) |
2/20 (10.00%) |
Chest discomfort |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Infusion site pain |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Non-cardiac chest pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
1/20 (5.00%) |
Influenza like illness |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
4/39 (10.26%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Early satiety |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Feeling abnormal |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Gait disturbance |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Oedema |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic haemorrhage |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Immune system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypersensitivity |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
|
|
|
Upper respiratory tract infection |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
2/7 (28.57%) |
0/4 (0.00%) |
6/39 (15.38%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
3/20 (15.00%) |
Oral candidiasis |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Pneumonia |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
1/8 (12.50%) |
2/20 (10.00%) |
Sinusitis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Bronchitis |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Bronchitis viral |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Folliculitis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Nasopharyngitis |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
4/39 (10.26%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Oesophageal candidiasis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Pharyngitis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Sepsis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Urinary tract infection |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
3/11 (27.27%) |
1/9 (11.11%) |
1/8 (12.50%) |
0/20 (0.00%) |
Influenza |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Candidiasis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Cellulitis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
1/20 (5.00%) |
Lung infection |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Oral herpes |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Bacterial sepsis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Clostridium difficile colitis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Peritonitis bacterial |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contusion |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
1/9 (11.11%) |
1/8 (12.50%) |
1/20 (5.00%) |
Excoriation |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Fall |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
0/20 (0.00%) |
Seroma |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Sunburn |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
5/39 (12.82%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Thermal burn |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Anaphylactic transfusion reaction |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Investigations |
|
|
|
|
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
7/39 (17.95%) |
1/11 (9.09%) |
0/9 (0.00%) |
1/8 (12.50%) |
1/20 (5.00%) |
Aspartate aminotransferase increased |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
1/7 (14.29%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/4 (0.00%) |
7/39 (17.95%) |
2/11 (18.18%) |
0/9 (0.00%) |
1/8 (12.50%) |
1/20 (5.00%) |
Blood alkaline phosphatase increased |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
4/39 (10.26%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Activated partial thromboplastin time prolonged |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Blood cholesterol increased |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
2/11 (18.18%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Lymphocyte count decreased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
International normalised ratio increased |
0/3 (0.00%) |
2/6 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
2/20 (10.00%) |
Weight decreased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
2/7 (28.57%) |
1/4 (25.00%) |
4/39 (10.26%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
4/20 (20.00%) |
Blood bilirubin increased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Blood thyroid stimulating hormone increased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Neutrophil count increased |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Occult blood positive |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Platelet count decreased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Prothrombin time prolonged |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
White blood cell count decreased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Lacrimation increased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
1/11 (9.09%) |
1/9 (11.11%) |
1/8 (12.50%) |
0/20 (0.00%) |
Blood creatinine increased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Blood creatinine phosphokinase increased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Blood glucose decreased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Troponin increased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Decreased appetite |
1/3 (33.33%) |
3/6 (50.00%) |
1/6 (16.67%) |
4/6 (66.67%) |
2/7 (28.57%) |
3/6 (50.00%) |
4/7 (57.14%) |
0/4 (0.00%) |
9/39 (23.08%) |
3/11 (27.27%) |
5/9 (55.56%) |
4/8 (50.00%) |
9/20 (45.00%) |
Hypophosphataemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
9/39 (23.08%) |
1/11 (9.09%) |
1/9 (11.11%) |
0/8 (0.00%) |
4/20 (20.00%) |
Dehydration |
1/3 (33.33%) |
3/6 (50.00%) |
1/6 (16.67%) |
2/6 (33.33%) |
1/7 (14.29%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/4 (0.00%) |
3/39 (7.69%) |
1/11 (9.09%) |
1/9 (11.11%) |
1/8 (12.50%) |
2/20 (10.00%) |
Hyperglycaemia |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypertriglyceridaemia |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypokalaemia |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
3/39 (7.69%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Abnormal loss of weight |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypercalcaemia |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hyponatraemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
0/9 (0.00%) |
2/8 (25.00%) |
1/20 (5.00%) |
Tumour lysis syndrome |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Weight increased |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
6/39 (15.38%) |
6/11 (54.55%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypomagnesaemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Fluid retention |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypercholesterolaemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypoalbuminaemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Hypoglycaemia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Malnutrition |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain |
2/3 (66.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
2/6 (33.33%) |
1/7 (14.29%) |
1/4 (25.00%) |
5/39 (12.82%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
4/20 (20.00%) |
Musculoskeletal pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/6 (33.33%) |
2/7 (28.57%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/4 (25.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
4/20 (20.00%) |
Arthralgia |
1/3 (33.33%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
24/39 (61.54%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
4/20 (20.00%) |
Myalgia |
1/3 (33.33%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
2/7 (28.57%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
4/39 (10.26%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Muscle spasms |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
4/39 (10.26%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Musculoskeletal chest pain |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
2/20 (10.00%) |
Pain in extremity |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
10/39 (25.64%) |
0/11 (0.00%) |
1/9 (11.11%) |
1/8 (12.50%) |
2/20 (10.00%) |
Bone pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Bunion |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Muscular weakness |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Joint swelling |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
6/39 (15.38%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Joint stiffness |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Arthritis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Fibromyalgia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Groin pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Muscle twitching |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Pain in jaw |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
0/20 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Tumour pain |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Melanocytic naevus |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Tumour associated fever |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysgeusia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
3/6 (50.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/4 (25.00%) |
14/39 (35.90%) |
2/11 (18.18%) |
1/9 (11.11%) |
2/8 (25.00%) |
2/20 (10.00%) |
Headache |
0/3 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
3/6 (50.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
13/39 (33.33%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
5/20 (25.00%) |
Cognitive disorder |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
7/39 (17.95%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Dizziness |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
2/6 (33.33%) |
1/7 (14.29%) |
1/6 (16.67%) |
2/7 (28.57%) |
1/4 (25.00%) |
11/39 (28.21%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
2/20 (10.00%) |
Aphasia |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Balance disorder |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Memory impairment |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
5/39 (12.82%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Burning sensation |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hypoaesthesia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Hypogeusia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Lethargy |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Neuropathy peripheral |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
4/39 (10.26%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
1/20 (5.00%) |
Paraesthesia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
3/39 (7.69%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
0/20 (0.00%) |
Parosmia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Sedation |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Syncope |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Tremor |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Amnesia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
4/39 (10.26%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Somnolence |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/4 (25.00%) |
1/39 (2.56%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Disturbance in attention |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Migraine |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Cerebrovascular accident |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Mental impairment |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Presyncope |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
1/20 (5.00%) |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Insomnia |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
7/39 (17.95%) |
4/11 (36.36%) |
2/9 (22.22%) |
2/8 (25.00%) |
2/20 (10.00%) |
Anxiety |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/4 (0.00%) |
4/39 (10.26%) |
1/11 (9.09%) |
1/9 (11.11%) |
0/8 (0.00%) |
3/20 (15.00%) |
Depression |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
2/6 (33.33%) |
0/7 (0.00%) |
1/4 (25.00%) |
5/39 (12.82%) |
1/11 (9.09%) |
2/9 (22.22%) |
0/8 (0.00%) |
2/20 (10.00%) |
Agitation |
0/3 (0.00%) |
0/6 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
1/9 (11.11%) |
0/8 (0.00%) |
0/20 (0.00%) |
Confusional state |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
1/7 (14.29%) |
1/4 (25.00%) |
3/39 (7.69%) |
1/11 (9.09%) |
1/9 (11.11%) |
1/8 (12.50%) |
0/20 (0.00%) |
Disorientation |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Distractibility |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Impulsive behaviour |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Mental status changes |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Abnormal dreams |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
2/39 (5.13%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hallucination |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Mood altered |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Sleep talking |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
1/8 (12.50%) |
0/20 (0.00%) |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematuria |
0/3 (0.00%) |
1/6 (16.67%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
5/39 (12.82%) |
1/11 (9.09%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Hydronephrosis |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Micturition urgency |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/7 (0.00%) |
1/6 (16.67%) |
0/7 (0.00%) |
0/4 (0.00%) |
1/39 (2.56%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Nocturia |
0/3 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
0/6 (0.00%) |
1/7 (14.29%) |
0/6 (0.00%) |
0/7 (0.00%) |
0/4 (0.00%) |
0/39 (0.00%) |
0/11 (0.00%) |
0/9 (0.00%) |
0/8 (0.00%) |
0/20 (0.00%) |
Pollakiuria |