Time Frame |
From start of Induction therapy to end of Maintenance therapy, up to 10 years
|
Adverse Event Reporting Description |
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
|
|
Arm/Group Title
|
T-ALL Induction Therapy
|
T-ALL Post Induction Therapy
|
T-ALL: Capizzi MTX Without Nelarabine
|
T-ALL: Capizzi MTX With Nelarabine
|
T-ALL: High Dose MTX Without Nelarabine
|
T-ALL: High Dose MTX With Nelarabine
|
T-LLy Induction Therapy
|
T-LLy Post Induction Therapy
|
T-LLy: Capizzi MTX Without Nelarabine
|
T-LLy: Capizzi MTX With Nelarabine
|
Arm/Group Description |
All patients diagnosed as T-ALL for...
|
T-ALL patients who went off therapy...
|
T-All patients who received Capizzi...
|
T-All patients who received Capizzi...
|
T-All patients who received High Do...
|
T-All patients who received High Do...
|
All patients diagnosed as T-LLy for...
|
T-LLy patients who went off therapy...
|
T-LLy patients who received Capizzi...
|
T-LLy patients who received Capizzi...
|
Arm/Group Description |
All patients diagnosed as T-ALL for induction
|
T-ALL patients who went off therapy at the end of induction, excluding patients who died at induction
|
T-All patients who received Capizzi MTX without Nelarabine
|
T-All patients who received Capizzi MTX with Nelarabine
|
T-All patients who received High Dose MTX without Nelarabine
|
T-All patients who received High Dose MTX with Nelarabine
|
All patients diagnosed as T-LLy for induction
|
T-LLy patients who went off therapy at the end of induction, excluding patients who died at induction
|
T-LLy patients who received Capizzi MTX without Nelarabine
|
T-LLy patients who received Capizzi MTX with Nelarabine
|
|
|
T-ALL Induction Therapy
|
T-ALL Post Induction Therapy
|
T-ALL: Capizzi MTX Without Nelarabine
|
T-ALL: Capizzi MTX With Nelarabine
|
T-ALL: High Dose MTX Without Nelarabine
|
T-ALL: High Dose MTX With Nelarabine
|
T-LLy Induction Therapy
|
T-LLy Post Induction Therapy
|
T-LLy: Capizzi MTX Without Nelarabine
|
T-LLy: Capizzi MTX With Nelarabine
|
|
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 |
6/1563 (0.38%)
|
|
39/368 (10.60%)
|
|
26/372 (6.99%)
|
|
10/147 (6.80%)
|
|
45/451 (9.98%)
|
|
35/219 (15.98%)
|
|
0/285 (0.00%)
|
|
8/80 (10.00%)
|
|
17/143 (11.89%)
|
|
5/62 (8.06%)
|
|
|
|
T-ALL Induction Therapy
|
T-ALL Post Induction Therapy
|
T-ALL: Capizzi MTX Without Nelarabine
|
T-ALL: Capizzi MTX With Nelarabine
|
T-ALL: High Dose MTX Without Nelarabine
|
T-ALL: High Dose MTX With Nelarabine
|
T-LLy Induction Therapy
|
T-LLy Post Induction Therapy
|
T-LLy: Capizzi MTX Without Nelarabine
|
T-LLy: Capizzi MTX With Nelarabine
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
25/1563 (1.60%)
|
|
1/368 (0.27%)
|
|
18/372 (4.84%)
|
|
44/147 (29.93%)
|
|
23/451 (5.10%)
|
|
66/219 (30.14%)
|
|
1/285 (0.35%)
|
|
0/80 (0.00%)
|
|
10/143 (6.99%)
|
|
20/62 (32.26%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
Anemia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Blood and lymphatic system disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Disseminated intravascular coagulation |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Febrile neutropenia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
2 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Leukocytosis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
Atrial fibrillation |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Left ventricular systolic dysfunction |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pericardial effusion |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Sinus tachycardia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
|
|
|
|
|
|
Blurred vision |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Optic nerve disorder |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
Abdominal distension |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Abdominal pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
4/219 (1.83%)
|
5 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Ascites |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Colitis |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Constipation |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dysphagia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Gastrointestinal disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Ileal perforation |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Intra-abdominal hemorrhage |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Mucositis oral |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Nausea |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Oral pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pancreatic necrosis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pancreatitis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
1/451 (0.22%)
|
1 |
5/219 (2.28%)
|
5 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
1/62 (1.61%)
|
1 |
Rectal ulcer |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Typhlitis |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Upper gastrointestinal hemorrhage |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vomiting |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
General disorders |
|
|
|
|
|
|
|
|
|
|
Death NOS |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Facial pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Fatigue |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Fever |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
3/147 (2.04%)
|
3 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
General disorders and administration site conditions - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Multi-organ failure |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
|
|
Hepatic failure |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hepatobiliary disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Portal hypertension |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Immune system disorders |
|
|
|
|
|
|
|
|
|
|
Allergic reaction |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
1/451 (0.22%)
|
1 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
2/62 (3.23%)
|
2 |
Anaphylaxis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
5/147 (3.40%)
|
5 |
2/451 (0.44%)
|
2 |
8/219 (3.65%)
|
8 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
3/62 (4.84%)
|
3 |
Immune system disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
Appendicitis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Catheter related infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Enterocolitis infectious |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Infections and infestations - Other, specify |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
2/147 (1.36%)
|
2 |
4/451 (0.89%)
|
4 |
6/219 (2.74%)
|
7 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Lung infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Meningitis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Sepsis |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
6/147 (4.08%)
|
7 |
2/451 (0.44%)
|
2 |
6/219 (2.74%)
|
8 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
2 |
2/62 (3.23%)
|
2 |
Skin infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Tooth infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Upper respiratory infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
Venous injury |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Investigations |
|
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
5/147 (3.40%)
|
5 |
0/451 (0.00%)
|
0 |
8/219 (3.65%)
|
8 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
2/62 (3.23%)
|
2 |
Alkaline phosphatase increased |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Aspartate aminotransferase increased |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
3/147 (2.04%)
|
3 |
0/451 (0.00%)
|
0 |
4/219 (1.83%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Blood bilirubin increased |
5/1563 (0.32%)
|
5 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
2 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
CPK increased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Creatinine increased |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Fibrinogen decreased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
GGT increased |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
INR increased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Investigations - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Lipase increased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
3/147 (2.04%)
|
3 |
0/451 (0.00%)
|
0 |
7/219 (3.20%)
|
7 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Lymphocyte count decreased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Neutrophil count decreased |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Platelet count decreased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Serum amylase increased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Weight loss |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
White blood cell decreased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
Acidosis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Anorexia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dehydration |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Glucose intolerance |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hyperglycemia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Hyperkalemia |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypernatremia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypertriglyceridemia |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
4/219 (1.83%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Hyperuricemia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypoalbuminemia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Hypocalcemia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypoglycemia |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypokalemia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
3/147 (2.04%)
|
3 |
1/451 (0.22%)
|
1 |
4/219 (1.83%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hyponatremia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypophosphatemia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Tumor lysis syndrome |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
Arthralgia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Avascular necrosis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Back pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Generalized muscle weakness |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Joint effusion |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Muscle weakness left-sided |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Muscle weakness lower limb |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorder - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
3/147 (2.04%)
|
3 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Myalgia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Myositis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pain in extremity |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
Leukemia secondary to oncology chemotherapy |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Treatment related secondary malignancy |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
Arachnoiditis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Ataxia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Depressed level of consciousness |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dysarthria |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dysphasia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Edema cerebral |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Encephalopathy |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
2 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Extrapyramidal disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Facial muscle weakness |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Facial nerve disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Glossopharyngeal nerve disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Headache |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypersomnia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypoglossal nerve disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Intracranial hemorrhage |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Ischemia cerebrovascular |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Leukoencephalopathy |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
4/219 (1.83%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
2/62 (3.23%)
|
2 |
Memory impairment |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Movements involuntary |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Nervous system disorders - Other, specify |
1/1563 (0.06%)
|
3 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Neuralgia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Paresthesia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Peripheral motor neuropathy |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
3/147 (2.04%)
|
4 |
0/451 (0.00%)
|
0 |
4/219 (1.83%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Peripheral sensory neuropathy |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
3/147 (2.04%)
|
3 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Recurrent laryngeal nerve palsy |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Reversible posterior leukoencephalopathy syndrome |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Seizure |
2/1563 (0.13%)
|
2 |
1/368 (0.27%)
|
1 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
4/62 (6.45%)
|
5 |
Stroke |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Syncope |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Transient ischemic attacks |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Pregnancy, puerperium and perinatal conditions |
|
|
|
|
|
|
|
|
|
|
Pregnancy, puerperium and perinatal conditions - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
Agitation |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Anxiety |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Confusion |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Delirium |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Depression |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Insomnia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Suicidal ideation |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
Acute kidney injury |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
4/219 (1.83%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Cystitis noninfective |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hematuria |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Renal and urinary disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Renal calculi |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Renal colic |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Urinary frequency |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
Adult respiratory distress syndrome |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Bronchopulmonary hemorrhage |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dyspnea |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Epistaxis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypoxia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Pleural effusion |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pneumonitis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pulmonary edema |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Respiratory failure |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Sore throat |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Wheezing |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
|
Rash maculo-papular |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Urticaria |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
Capillary leak syndrome |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hematoma |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypertension |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypotension |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
3/147 (2.04%)
|
3 |
2/451 (0.44%)
|
2 |
6/219 (2.74%)
|
9 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Thromboembolic event |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vascular disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Term from vocabulary, CTCv4
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
T-ALL Induction Therapy
|
T-ALL Post Induction Therapy
|
T-ALL: Capizzi MTX Without Nelarabine
|
T-ALL: Capizzi MTX With Nelarabine
|
T-ALL: High Dose MTX Without Nelarabine
|
T-ALL: High Dose MTX With Nelarabine
|
T-LLy Induction Therapy
|
T-LLy Post Induction Therapy
|
T-LLy: Capizzi MTX Without Nelarabine
|
T-LLy: Capizzi MTX With Nelarabine
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
983/1563 (62.89%)
|
|
0/368 (0.00%)
|
|
357/372 (95.97%)
|
|
134/147 (91.16%)
|
|
436/451 (96.67%)
|
|
197/219 (89.95%)
|
|
152/285 (53.33%)
|
|
4/80 (5.00%)
|
|
140/143 (97.90%)
|
|
55/62 (88.71%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
|
|
|
|
|
|
Anemia |
57/1563 (3.65%)
|
60 |
0/368 (0.00%)
|
0 |
87/372 (23.39%)
|
139 |
26/147 (17.69%)
|
37 |
93/451 (20.62%)
|
142 |
25/219 (11.42%)
|
29 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
23/143 (16.08%)
|
33 |
9/62 (14.52%)
|
12 |
Blood and lymphatic system disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
3/451 (0.67%)
|
5 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
1/80 (1.25%)
|
1 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Bone marrow hypocellular |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Disseminated intravascular coagulation |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Febrile neutropenia |
96/1563 (6.14%)
|
101 |
0/368 (0.00%)
|
0 |
233/372 (62.63%)
|
504 |
87/147 (59.18%)
|
153 |
283/451 (62.75%)
|
614 |
102/219 (46.58%)
|
168 |
3/285 (1.05%)
|
3 |
2/80 (2.50%)
|
2 |
91/143 (63.64%)
|
160 |
27/62 (43.55%)
|
52 |
Hemolysis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hemolytic uremic syndrome |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Leukocytosis |
5/1563 (0.32%)
|
5 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
|
|
|
|
|
|
Asystole |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Cardiac disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Chest pain - cardiac |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Left ventricular systolic dysfunction |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Pericardial effusion |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pericardial tamponade |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Sinus bradycardia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Sinus tachycardia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
3 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Supraventricular tachycardia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Ventricular tachycardia |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
|
|
|
|
|
|
|
|
Ear pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hearing impaired |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Middle ear inflammation |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Tinnitus |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
|
|
|
|
|
|
|
Adrenal insufficiency |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Cushingoid |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypothyroidism |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
|
|
|
|
|
|
Blurred vision |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Conjunctivitis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Extraocular muscle paresis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Eye disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Eyelid function disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Night blindness |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Optic nerve disorder |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Papilledema |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Photophobia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vitreous hemorrhage |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
|
|
|
|
|
|
Abdominal distension |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Abdominal pain |
22/1563 (1.41%)
|
22 |
0/368 (0.00%)
|
0 |
28/372 (7.53%)
|
34 |
8/147 (5.44%)
|
13 |
19/451 (4.21%)
|
30 |
13/219 (5.94%)
|
15 |
3/285 (1.05%)
|
3 |
0/80 (0.00%)
|
0 |
6/143 (4.20%)
|
7 |
4/62 (6.45%)
|
6 |
Anal mucositis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
5/372 (1.34%)
|
5 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Anal pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Ascites |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Colitis |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
2/147 (1.36%)
|
2 |
9/451 (2.00%)
|
9 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
7/143 (4.90%)
|
7 |
1/62 (1.61%)
|
3 |
Colonic perforation |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Constipation |
18/1563 (1.15%)
|
18 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
4/219 (1.83%)
|
4 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
2/62 (3.23%)
|
3 |
Dental caries |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Diarrhea |
14/1563 (0.90%)
|
14 |
0/368 (0.00%)
|
0 |
20/372 (5.38%)
|
21 |
7/147 (4.76%)
|
7 |
26/451 (5.76%)
|
27 |
8/219 (3.65%)
|
8 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
2/62 (3.23%)
|
6 |
Duodenal obstruction |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dyspepsia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dysphagia |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Enterocolitis |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Esophageal pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Esophagitis |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Gastritis |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
1/62 (1.61%)
|
1 |
Gastroesophageal reflux disease |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Gastrointestinal disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
2/219 (0.91%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
3 |
0/62 (0.00%)
|
0 |
Gastroparesis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Gingival pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hemorrhoidal hemorrhage |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hemorrhoids |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Ileus |
10/1563 (0.64%)
|
10 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
4 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Intra-abdominal hemorrhage |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Lip pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Lower gastrointestinal hemorrhage |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Mucositis oral |
17/1563 (1.09%)
|
17 |
0/368 (0.00%)
|
0 |
54/372 (14.52%)
|
64 |
19/147 (12.93%)
|
21 |
77/451 (17.07%)
|
83 |
35/219 (15.98%)
|
37 |
3/285 (1.05%)
|
3 |
0/80 (0.00%)
|
0 |
24/143 (16.78%)
|
28 |
9/62 (14.52%)
|
10 |
Nausea |
9/1563 (0.58%)
|
9 |
0/368 (0.00%)
|
0 |
32/372 (8.60%)
|
37 |
14/147 (9.52%)
|
18 |
20/451 (4.43%)
|
25 |
17/219 (7.76%)
|
18 |
5/285 (1.75%)
|
5 |
0/80 (0.00%)
|
0 |
13/143 (9.09%)
|
15 |
6/62 (9.68%)
|
9 |
Oral hemorrhage |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Oral pain |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
10/372 (2.69%)
|
12 |
1/147 (0.68%)
|
1 |
9/451 (2.00%)
|
9 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Pancreatic duct stenosis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pancreatic fistula |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pancreatic hemorrhage |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pancreatic necrosis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pancreatitis |
5/1563 (0.32%)
|
5 |
0/368 (0.00%)
|
0 |
9/372 (2.42%)
|
9 |
10/147 (6.80%)
|
13 |
15/451 (3.33%)
|
19 |
8/219 (3.65%)
|
8 |
1/285 (0.35%)
|
1 |
2/80 (2.50%)
|
2 |
9/143 (6.29%)
|
9 |
1/62 (1.61%)
|
1 |
Proctitis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Rectal fistula |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Rectal mucositis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Rectal pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
5 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Small intestinal mucositis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Stomach pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Toothache |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Typhlitis |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
12/372 (3.23%)
|
13 |
3/147 (2.04%)
|
3 |
7/451 (1.55%)
|
7 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
5/143 (3.50%)
|
5 |
1/62 (1.61%)
|
1 |
Vomiting |
14/1563 (0.90%)
|
14 |
0/368 (0.00%)
|
0 |
40/372 (10.75%)
|
51 |
14/147 (9.52%)
|
18 |
38/451 (8.43%)
|
47 |
19/219 (8.68%)
|
23 |
3/285 (1.05%)
|
3 |
0/80 (0.00%)
|
0 |
14/143 (9.79%)
|
16 |
9/62 (14.52%)
|
14 |
General disorders |
|
|
|
|
|
|
|
|
|
|
Chills |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Facial pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Fatigue |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
9/372 (2.42%)
|
10 |
0/147 (0.00%)
|
0 |
4/451 (0.89%)
|
4 |
4/219 (1.83%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
4/143 (2.80%)
|
4 |
3/62 (4.84%)
|
3 |
Fever |
12/1563 (0.77%)
|
12 |
0/368 (0.00%)
|
0 |
49/372 (13.17%)
|
62 |
16/147 (10.88%)
|
18 |
42/451 (9.31%)
|
48 |
15/219 (6.85%)
|
17 |
1/285 (0.35%)
|
1 |
1/80 (1.25%)
|
1 |
10/143 (6.99%)
|
11 |
7/62 (11.29%)
|
9 |
Flu like symptoms |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Gait disturbance |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
General disorders and administration site conditions - Other, specify |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
2 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypothermia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Infusion related reaction |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Injection site reaction |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Irritability |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Multi-organ failure |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Non-cardiac chest pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Pain |
9/1563 (0.58%)
|
9 |
0/368 (0.00%)
|
0 |
5/372 (1.34%)
|
7 |
0/147 (0.00%)
|
0 |
10/451 (2.22%)
|
10 |
3/219 (1.37%)
|
3 |
4/285 (1.40%)
|
4 |
0/80 (0.00%)
|
0 |
6/143 (4.20%)
|
6 |
1/62 (1.61%)
|
1 |
Hepatobiliary disorders |
|
|
|
|
|
|
|
|
|
|
Cholecystitis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
9/372 (2.42%)
|
9 |
1/147 (0.68%)
|
1 |
3/451 (0.67%)
|
3 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
1/80 (1.25%)
|
1 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Gallbladder obstruction |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Gallbladder pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hepatic failure |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Hepatic pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hepatobiliary disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
5/451 (1.11%)
|
6 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
0/62 (0.00%)
|
0 |
Portal hypertension |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Immune system disorders |
|
|
|
|
|
|
|
|
|
|
Allergic reaction |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
17/372 (4.57%)
|
18 |
6/147 (4.08%)
|
6 |
18/451 (3.99%)
|
18 |
8/219 (3.65%)
|
9 |
0/285 (0.00%)
|
0 |
1/80 (1.25%)
|
1 |
10/143 (6.99%)
|
10 |
5/62 (8.06%)
|
5 |
Anaphylaxis |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
40/372 (10.75%)
|
42 |
10/147 (6.80%)
|
10 |
51/451 (11.31%)
|
53 |
13/219 (5.94%)
|
13 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
10/143 (6.99%)
|
10 |
2/62 (3.23%)
|
2 |
Immune system disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
6/372 (1.61%)
|
9 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
6 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Infections and infestations |
|
|
|
|
|
|
|
|
|
|
Abdominal infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Anorectal infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Appendicitis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
3/147 (2.04%)
|
3 |
6/451 (1.33%)
|
6 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Appendicitis perforated |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Biliary tract infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Bladder infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Bone infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Bronchial infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Catheter related infection |
12/1563 (0.77%)
|
13 |
0/368 (0.00%)
|
0 |
13/372 (3.49%)
|
17 |
3/147 (2.04%)
|
3 |
20/451 (4.43%)
|
27 |
9/219 (4.11%)
|
13 |
4/285 (1.40%)
|
4 |
0/80 (0.00%)
|
0 |
10/143 (6.99%)
|
12 |
3/62 (4.84%)
|
3 |
Conjunctivitis infective |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Cranial nerve infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Device related infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Duodenal infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Endocarditis infective |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Endophthalmitis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Enterocolitis infectious |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
18/372 (4.84%)
|
19 |
2/147 (1.36%)
|
2 |
15/451 (3.33%)
|
17 |
7/219 (3.20%)
|
8 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
1/62 (1.61%)
|
1 |
Esophageal infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Eye infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Gum infection |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Hepatic infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hepatitis viral |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Infections and infestations - Other, specify |
102/1563 (6.53%)
|
127 |
0/368 (0.00%)
|
0 |
145/372 (38.98%)
|
280 |
41/147 (27.89%)
|
61 |
184/451 (40.80%)
|
298 |
53/219 (24.20%)
|
77 |
15/285 (5.26%)
|
17 |
0/80 (0.00%)
|
0 |
31/143 (21.68%)
|
35 |
8/62 (12.90%)
|
10 |
Infective myositis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Joint infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Kidney infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Lip infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
2/147 (1.36%)
|
2 |
2/451 (0.44%)
|
2 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Lung infection |
13/1563 (0.83%)
|
14 |
0/368 (0.00%)
|
0 |
38/372 (10.22%)
|
44 |
12/147 (8.16%)
|
15 |
41/451 (9.09%)
|
52 |
14/219 (6.39%)
|
16 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
9/143 (6.29%)
|
9 |
4/62 (6.45%)
|
4 |
Lymph gland infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Mucosal infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
8/372 (2.15%)
|
8 |
1/147 (0.68%)
|
1 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Nail infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Otitis externa |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Otitis media |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
9/372 (2.42%)
|
11 |
4/147 (2.72%)
|
4 |
19/451 (4.21%)
|
21 |
6/219 (2.74%)
|
6 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
8/143 (5.59%)
|
9 |
2/62 (3.23%)
|
2 |
Pancreas infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Paronychia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pelvic infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Penile infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Periorbital infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Peripheral nerve infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Peritoneal infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pharyngitis |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
5/372 (1.34%)
|
5 |
2/147 (1.36%)
|
2 |
2/451 (0.44%)
|
2 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Pleural infection |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Rash pustular |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Rhinitis infective |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Salivary gland infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Sepsis |
13/1563 (0.83%)
|
13 |
0/368 (0.00%)
|
0 |
7/372 (1.88%)
|
7 |
4/147 (2.72%)
|
5 |
7/451 (1.55%)
|
8 |
2/219 (0.91%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
6/143 (4.20%)
|
7 |
1/62 (1.61%)
|
1 |
Sinusitis |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
15/372 (4.03%)
|
20 |
7/147 (4.76%)
|
7 |
16/451 (3.55%)
|
17 |
4/219 (1.83%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
2/62 (3.23%)
|
2 |
Skin infection |
18/1563 (1.15%)
|
19 |
0/368 (0.00%)
|
0 |
28/372 (7.53%)
|
33 |
8/147 (5.44%)
|
11 |
29/451 (6.43%)
|
29 |
13/219 (5.94%)
|
15 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
7/143 (4.90%)
|
8 |
3/62 (4.84%)
|
3 |
Small intestine infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Soft tissue infection |
5/1563 (0.32%)
|
5 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
2 |
1/147 (0.68%)
|
1 |
6/451 (1.33%)
|
7 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
1/62 (1.61%)
|
1 |
Splenic infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Tooth infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Tracheitis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
2 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Upper respiratory infection |
7/1563 (0.45%)
|
8 |
0/368 (0.00%)
|
0 |
49/372 (13.17%)
|
63 |
17/147 (11.56%)
|
18 |
45/451 (9.98%)
|
55 |
20/219 (9.13%)
|
23 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
17/143 (11.89%)
|
23 |
8/62 (12.90%)
|
11 |
Urethral infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Urinary tract infection |
7/1563 (0.45%)
|
7 |
0/368 (0.00%)
|
0 |
15/372 (4.03%)
|
15 |
2/147 (1.36%)
|
2 |
10/451 (2.22%)
|
11 |
9/219 (4.11%)
|
11 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
8/143 (5.59%)
|
9 |
0/62 (0.00%)
|
0 |
Vaginal infection |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
3 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Vulval infection |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Wound infection |
5/1563 (0.32%)
|
6 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
4 |
0/147 (0.00%)
|
0 |
6/451 (1.33%)
|
7 |
2/219 (0.91%)
|
2 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
|
|
|
|
|
|
Bruising |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Fall |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Fracture |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Injury to superior vena cava |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Injury, poisoning and procedural complications - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Postoperative thoracic procedure complication |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Prolapse of intestinal stoma |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Seroma |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vascular access complication |
12/1563 (0.77%)
|
12 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
2/219 (0.91%)
|
2 |
4/285 (1.40%)
|
4 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Venous injury |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Wound complication |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Wound dehiscence |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Investigations |
|
|
|
|
|
|
|
|
|
|
Activated partial thromboplastin time prolonged |
16/1563 (1.02%)
|
16 |
0/368 (0.00%)
|
0 |
6/372 (1.61%)
|
8 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
4/143 (2.80%)
|
4 |
0/62 (0.00%)
|
0 |
Alanine aminotransferase increased |
133/1563 (8.51%)
|
133 |
0/368 (0.00%)
|
0 |
157/372 (42.20%)
|
456 |
62/147 (42.18%)
|
166 |
182/451 (40.35%)
|
493 |
83/219 (37.90%)
|
217 |
25/285 (8.77%)
|
25 |
1/80 (1.25%)
|
1 |
49/143 (34.27%)
|
97 |
21/62 (33.87%)
|
50 |
Alkaline phosphatase increased |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
7/372 (1.88%)
|
7 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
2 |
Aspartate aminotransferase increased |
72/1563 (4.61%)
|
72 |
0/368 (0.00%)
|
0 |
86/372 (23.12%)
|
133 |
35/147 (23.81%)
|
59 |
99/451 (21.95%)
|
145 |
36/219 (16.44%)
|
54 |
6/285 (2.11%)
|
6 |
1/80 (1.25%)
|
2 |
27/143 (18.88%)
|
40 |
10/62 (16.13%)
|
12 |
Blood antidiuretic hormone abnormal |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Blood bilirubin increased |
29/1563 (1.86%)
|
29 |
0/368 (0.00%)
|
0 |
42/372 (11.29%)
|
66 |
20/147 (13.61%)
|
31 |
52/451 (11.53%)
|
85 |
20/219 (9.13%)
|
40 |
4/285 (1.40%)
|
4 |
1/80 (1.25%)
|
1 |
25/143 (17.48%)
|
29 |
6/62 (9.68%)
|
8 |
Blood gonadotrophin abnormal |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Blood prolactin abnormal |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
CPK increased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Cholesterol high |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
5 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
3 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Creatinine increased |
21/1563 (1.34%)
|
21 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
0/62 (0.00%)
|
0 |
Fibrinogen decreased |
75/1563 (4.80%)
|
76 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
3/147 (2.04%)
|
4 |
3/451 (0.67%)
|
5 |
1/219 (0.46%)
|
1 |
8/285 (2.81%)
|
8 |
1/80 (1.25%)
|
1 |
5/143 (3.50%)
|
5 |
0/62 (0.00%)
|
0 |
GGT increased |
22/1563 (1.41%)
|
22 |
0/368 (0.00%)
|
0 |
14/372 (3.76%)
|
27 |
3/147 (2.04%)
|
4 |
12/451 (2.66%)
|
24 |
6/219 (2.74%)
|
9 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
6/143 (4.20%)
|
8 |
1/62 (1.61%)
|
2 |
Growth hormone abnormal |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hemoglobin increased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
INR increased |
5/1563 (0.32%)
|
5 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
0/147 (0.00%)
|
0 |
4/451 (0.89%)
|
4 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Investigations - Other, specify |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
4/451 (0.89%)
|
4 |
2/219 (0.91%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Lipase increased |
15/1563 (0.96%)
|
15 |
0/368 (0.00%)
|
0 |
15/372 (4.03%)
|
19 |
9/147 (6.12%)
|
13 |
26/451 (5.76%)
|
31 |
4/219 (1.83%)
|
4 |
3/285 (1.05%)
|
3 |
1/80 (1.25%)
|
1 |
10/143 (6.99%)
|
12 |
3/62 (4.84%)
|
3 |
Lymphocyte count decreased |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
24/372 (6.45%)
|
41 |
9/147 (6.12%)
|
15 |
28/451 (6.21%)
|
44 |
13/219 (5.94%)
|
18 |
3/285 (1.05%)
|
3 |
0/80 (0.00%)
|
0 |
7/143 (4.90%)
|
13 |
3/62 (4.84%)
|
5 |
Neutrophil count decreased |
97/1563 (6.21%)
|
98 |
0/368 (0.00%)
|
0 |
276/372 (74.19%)
|
710 |
89/147 (60.54%)
|
189 |
331/451 (73.39%)
|
1010 |
116/219 (52.97%)
|
277 |
8/285 (2.81%)
|
8 |
1/80 (1.25%)
|
1 |
100/143 (69.93%)
|
208 |
35/62 (56.45%)
|
76 |
Platelet count decreased |
61/1563 (3.90%)
|
61 |
0/368 (0.00%)
|
0 |
117/372 (31.45%)
|
201 |
29/147 (19.73%)
|
44 |
150/451 (33.26%)
|
251 |
50/219 (22.83%)
|
75 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
37/143 (25.87%)
|
53 |
13/62 (20.97%)
|
19 |
Serum amylase increased |
11/1563 (0.70%)
|
11 |
0/368 (0.00%)
|
0 |
11/372 (2.96%)
|
13 |
2/147 (1.36%)
|
4 |
17/451 (3.77%)
|
17 |
5/219 (2.28%)
|
5 |
1/285 (0.35%)
|
1 |
1/80 (1.25%)
|
1 |
5/143 (3.50%)
|
5 |
1/62 (1.61%)
|
2 |
Urine output decreased |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Weight gain |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
6 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Weight loss |
17/1563 (1.09%)
|
17 |
0/368 (0.00%)
|
0 |
23/372 (6.18%)
|
25 |
6/147 (4.08%)
|
6 |
16/451 (3.55%)
|
17 |
5/219 (2.28%)
|
5 |
5/285 (1.75%)
|
5 |
0/80 (0.00%)
|
0 |
6/143 (4.20%)
|
8 |
3/62 (4.84%)
|
3 |
White blood cell decreased |
54/1563 (3.45%)
|
54 |
0/368 (0.00%)
|
0 |
110/372 (29.57%)
|
253 |
35/147 (23.81%)
|
62 |
125/451 (27.72%)
|
353 |
40/219 (18.26%)
|
70 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
38/143 (26.57%)
|
61 |
11/62 (17.74%)
|
18 |
Metabolism and nutrition disorders |
|
|
|
|
|
|
|
|
|
|
Acidosis |
7/1563 (0.45%)
|
7 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Alkalosis |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Anorexia |
27/1563 (1.73%)
|
27 |
0/368 (0.00%)
|
0 |
38/372 (10.22%)
|
45 |
17/147 (11.56%)
|
35 |
32/451 (7.10%)
|
45 |
16/219 (7.31%)
|
21 |
4/285 (1.40%)
|
4 |
0/80 (0.00%)
|
0 |
12/143 (8.39%)
|
13 |
6/62 (9.68%)
|
7 |
Dehydration |
15/1563 (0.96%)
|
15 |
0/368 (0.00%)
|
0 |
51/372 (13.71%)
|
62 |
22/147 (14.97%)
|
25 |
30/451 (6.65%)
|
34 |
15/219 (6.85%)
|
18 |
9/285 (3.16%)
|
9 |
0/80 (0.00%)
|
0 |
11/143 (7.69%)
|
13 |
7/62 (11.29%)
|
7 |
Glucose intolerance |
8/1563 (0.51%)
|
8 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypercalcemia |
10/1563 (0.64%)
|
10 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Hyperglycemia |
216/1563 (13.82%)
|
217 |
0/368 (0.00%)
|
0 |
14/372 (3.76%)
|
16 |
4/147 (2.72%)
|
7 |
42/451 (9.31%)
|
67 |
14/219 (6.39%)
|
22 |
17/285 (5.96%)
|
18 |
0/80 (0.00%)
|
0 |
15/143 (10.49%)
|
21 |
2/62 (3.23%)
|
2 |
Hyperkalemia |
80/1563 (5.12%)
|
80 |
0/368 (0.00%)
|
0 |
6/372 (1.61%)
|
8 |
3/147 (2.04%)
|
4 |
12/451 (2.66%)
|
12 |
3/219 (1.37%)
|
3 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
4/143 (2.80%)
|
4 |
1/62 (1.61%)
|
1 |
Hypermagnesemia |
8/1563 (0.51%)
|
8 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Hypernatremia |
9/1563 (0.58%)
|
9 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Hypertriglyceridemia |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
10/372 (2.69%)
|
12 |
1/147 (0.68%)
|
1 |
6/451 (1.33%)
|
8 |
1/219 (0.46%)
|
1 |
3/285 (1.05%)
|
3 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
1/62 (1.61%)
|
1 |
Hyperuricemia |
37/1563 (2.37%)
|
37 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypoalbuminemia |
19/1563 (1.22%)
|
19 |
0/368 (0.00%)
|
0 |
16/372 (4.30%)
|
18 |
4/147 (2.72%)
|
6 |
24/451 (5.32%)
|
26 |
10/219 (4.57%)
|
10 |
10/285 (3.51%)
|
10 |
0/80 (0.00%)
|
0 |
7/143 (4.90%)
|
9 |
2/62 (3.23%)
|
2 |
Hypocalcemia |
199/1563 (12.73%)
|
200 |
0/368 (0.00%)
|
0 |
16/372 (4.30%)
|
16 |
6/147 (4.08%)
|
6 |
14/451 (3.10%)
|
15 |
8/219 (3.65%)
|
8 |
6/285 (2.11%)
|
6 |
0/80 (0.00%)
|
0 |
5/143 (3.50%)
|
5 |
2/62 (3.23%)
|
3 |
Hypoglycemia |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
13/372 (3.49%)
|
18 |
4/147 (2.72%)
|
4 |
9/451 (2.00%)
|
11 |
6/219 (2.74%)
|
6 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Hypokalemia |
99/1563 (6.33%)
|
100 |
0/368 (0.00%)
|
0 |
58/372 (15.59%)
|
71 |
15/147 (10.20%)
|
20 |
101/451 (22.39%)
|
127 |
41/219 (18.72%)
|
48 |
10/285 (3.51%)
|
10 |
0/80 (0.00%)
|
0 |
14/143 (9.79%)
|
16 |
4/62 (6.45%)
|
5 |
Hypomagnesemia |
5/1563 (0.32%)
|
5 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hyponatremia |
116/1563 (7.42%)
|
116 |
0/368 (0.00%)
|
0 |
16/372 (4.30%)
|
17 |
7/147 (4.76%)
|
9 |
26/451 (5.76%)
|
28 |
10/219 (4.57%)
|
10 |
21/285 (7.37%)
|
21 |
0/80 (0.00%)
|
0 |
11/143 (7.69%)
|
13 |
1/62 (1.61%)
|
1 |
Hypophosphatemia |
44/1563 (2.82%)
|
44 |
0/368 (0.00%)
|
0 |
9/372 (2.42%)
|
9 |
3/147 (2.04%)
|
3 |
13/451 (2.88%)
|
14 |
5/219 (2.28%)
|
5 |
6/285 (2.11%)
|
6 |
0/80 (0.00%)
|
0 |
6/143 (4.20%)
|
7 |
2/62 (3.23%)
|
2 |
Iron overload |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
4 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Metabolism and nutrition disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Obesity |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Tumor lysis syndrome |
135/1563 (8.64%)
|
135 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
5/285 (1.75%)
|
5 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
|
|
|
|
|
|
Arthralgia |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
8 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Avascular necrosis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
37/372 (9.95%)
|
66 |
5/147 (3.40%)
|
7 |
34/451 (7.54%)
|
51 |
9/219 (4.11%)
|
11 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
15/143 (10.49%)
|
26 |
7/62 (11.29%)
|
11 |
Back pain |
10/1563 (0.64%)
|
10 |
0/368 (0.00%)
|
0 |
9/372 (2.42%)
|
10 |
0/147 (0.00%)
|
0 |
10/451 (2.22%)
|
11 |
8/219 (3.65%)
|
10 |
4/285 (1.40%)
|
4 |
0/80 (0.00%)
|
0 |
5/143 (3.50%)
|
11 |
2/62 (3.23%)
|
2 |
Bone pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
5/451 (1.11%)
|
7 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Buttock pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Chest wall pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Flank pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Generalized muscle weakness |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
2/219 (0.91%)
|
2 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Joint effusion |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Joint range of motion decreased |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Muscle weakness left-sided |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Muscle weakness lower limb |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Muscle weakness right-sided |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Muscle weakness trunk |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Muscle weakness upper limb |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorder - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Myalgia |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Myositis |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Neck pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Osteoporosis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pain in extremity |
11/1563 (0.70%)
|
11 |
0/368 (0.00%)
|
0 |
17/372 (4.57%)
|
17 |
6/147 (4.08%)
|
6 |
10/451 (2.22%)
|
12 |
5/219 (2.28%)
|
7 |
6/285 (2.11%)
|
6 |
0/80 (0.00%)
|
0 |
4/143 (2.80%)
|
4 |
1/62 (1.61%)
|
3 |
Scoliosis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
3 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
|
|
|
|
|
|
Myelodysplastic syndrome |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Tumor pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
|
|
|
|
|
|
Abducens nerve disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Amnesia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Ataxia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
1/147 (0.68%)
|
2 |
3/451 (0.67%)
|
3 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Cerebrospinal fluid leakage |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
1/62 (1.61%)
|
1 |
Cognitive disturbance |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
5/372 (1.34%)
|
5 |
1/147 (0.68%)
|
1 |
7/451 (1.55%)
|
8 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Concentration impairment |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Depressed level of consciousness |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
9/372 (2.42%)
|
10 |
2/147 (1.36%)
|
2 |
7/451 (1.55%)
|
7 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Dizziness |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
9/372 (2.42%)
|
11 |
5/147 (3.40%)
|
12 |
4/451 (0.89%)
|
6 |
10/219 (4.57%)
|
14 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
3 |
1/62 (1.61%)
|
1 |
Dysarthria |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
3/219 (1.37%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
0/62 (0.00%)
|
0 |
Dysesthesia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Dysgeusia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dysphasia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Encephalopathy |
9/1563 (0.58%)
|
9 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
8/451 (1.77%)
|
8 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
0/62 (0.00%)
|
0 |
Extrapyramidal disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
4/451 (0.89%)
|
4 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Facial muscle weakness |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Facial nerve disorder |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
3 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Headache |
43/1563 (2.75%)
|
44 |
0/368 (0.00%)
|
0 |
37/372 (9.95%)
|
65 |
16/147 (10.88%)
|
33 |
37/451 (8.20%)
|
68 |
34/219 (15.53%)
|
55 |
12/285 (4.21%)
|
12 |
1/80 (1.25%)
|
1 |
19/143 (13.29%)
|
32 |
9/62 (14.52%)
|
25 |
Hydrocephalus |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypersomnia |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
IVth nerve disorder |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Intracranial hemorrhage |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Ischemia cerebrovascular |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Lethargy |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
3 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Leukoencephalopathy |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
6/372 (1.61%)
|
6 |
4/147 (2.72%)
|
4 |
10/451 (2.22%)
|
10 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
2/62 (3.23%)
|
2 |
Memory impairment |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
2/147 (1.36%)
|
2 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
2 |
Meningismus |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Movements involuntary |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Nervous system disorders - Other, specify |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
6/372 (1.61%)
|
6 |
1/147 (0.68%)
|
1 |
12/451 (2.66%)
|
13 |
3/219 (1.37%)
|
3 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
0/62 (0.00%)
|
0 |
Neuralgia |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
6/372 (1.61%)
|
7 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Oculomotor nerve disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
4 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Paresthesia |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
2/147 (1.36%)
|
2 |
1/451 (0.22%)
|
1 |
3/219 (1.37%)
|
3 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
4/143 (2.80%)
|
5 |
4/62 (6.45%)
|
6 |
Peripheral motor neuropathy |
87/1563 (5.57%)
|
87 |
0/368 (0.00%)
|
0 |
116/372 (31.18%)
|
335 |
45/147 (30.61%)
|
129 |
106/451 (23.50%)
|
273 |
57/219 (26.03%)
|
148 |
8/285 (2.81%)
|
8 |
1/80 (1.25%)
|
1 |
31/143 (21.68%)
|
72 |
23/62 (37.10%)
|
41 |
Peripheral sensory neuropathy |
181/1563 (11.58%)
|
183 |
0/368 (0.00%)
|
0 |
106/372 (28.49%)
|
273 |
41/147 (27.89%)
|
118 |
91/451 (20.18%)
|
262 |
46/219 (21.00%)
|
132 |
38/285 (13.33%)
|
38 |
0/80 (0.00%)
|
0 |
33/143 (23.08%)
|
98 |
20/62 (32.26%)
|
60 |
Presyncope |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
2/147 (1.36%)
|
2 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pyramidal tract syndrome |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Reversible posterior leukoencephalopathy syndrome |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Seizure |
31/1563 (1.98%)
|
32 |
0/368 (0.00%)
|
0 |
12/372 (3.23%)
|
20 |
2/147 (1.36%)
|
2 |
19/451 (4.21%)
|
20 |
4/219 (1.83%)
|
4 |
2/285 (0.70%)
|
2 |
1/80 (1.25%)
|
1 |
3/143 (2.10%)
|
3 |
3/62 (4.84%)
|
4 |
Somnolence |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
8/147 (5.44%)
|
8 |
10/451 (2.22%)
|
10 |
11/219 (5.02%)
|
12 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Stroke |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Syncope |
7/1563 (0.45%)
|
8 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
3/147 (2.04%)
|
3 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
4/143 (2.80%)
|
4 |
4/62 (6.45%)
|
4 |
Transient ischemic attacks |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
3 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Tremor |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
5/372 (1.34%)
|
7 |
5/147 (3.40%)
|
6 |
3/451 (0.67%)
|
3 |
6/219 (2.74%)
|
6 |
2/285 (0.70%)
|
3 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
2 |
2/62 (3.23%)
|
2 |
Trigeminal nerve disorder |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vagus nerve disorder |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vasovagal reaction |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
|
|
|
|
|
|
Agitation |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
2/147 (1.36%)
|
2 |
3/451 (0.67%)
|
3 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
2/62 (3.23%)
|
3 |
Anxiety |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
8/372 (2.15%)
|
8 |
1/147 (0.68%)
|
1 |
3/451 (0.67%)
|
3 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Confusion |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Delirium |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Depression |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
7/372 (1.88%)
|
8 |
2/147 (1.36%)
|
2 |
4/451 (0.89%)
|
4 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Euphoria |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hallucinations |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Insomnia |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Personality change |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Psychiatric disorders - Other, specify |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Psychosis |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
0/147 (0.00%)
|
0 |
5/451 (1.11%)
|
5 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Suicidal ideation |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
4 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Suicide attempt |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
|
|
|
|
|
|
Acute kidney injury |
24/1563 (1.54%)
|
24 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
3/451 (0.67%)
|
3 |
2/219 (0.91%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
3 |
0/62 (0.00%)
|
0 |
Chronic kidney disease |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Cystitis noninfective |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hematuria |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Proteinuria |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Renal and urinary disorders - Other, specify |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Renal calculi |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
5 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
3 |
Renal colic |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Renal hemorrhage |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Urinary frequency |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Urinary retention |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Urinary tract obstruction |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Urinary tract pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
|
|
|
|
|
|
|
Pelvic pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Perineal pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Testicular pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vaginal dryness |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vaginal inflammation |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Vaginal pain |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
|
|
|
|
|
|
Adult respiratory distress syndrome |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Allergic rhinitis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Aspiration |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Atelectasis |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
3 |
0/62 (0.00%)
|
0 |
Bronchial obstruction |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Bronchopulmonary hemorrhage |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Bronchospasm |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Cough |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
5/372 (1.34%)
|
5 |
0/147 (0.00%)
|
0 |
4/451 (0.89%)
|
4 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Dyspnea |
6/1563 (0.38%)
|
6 |
0/368 (0.00%)
|
0 |
3/372 (0.81%)
|
3 |
3/147 (2.04%)
|
3 |
2/451 (0.44%)
|
2 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
1/62 (1.61%)
|
2 |
Epistaxis |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
5/372 (1.34%)
|
5 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
3/219 (1.37%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Hoarseness |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypoxia |
31/1563 (1.98%)
|
31 |
0/368 (0.00%)
|
0 |
11/372 (2.96%)
|
12 |
3/147 (2.04%)
|
3 |
12/451 (2.66%)
|
12 |
3/219 (1.37%)
|
4 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
3/143 (2.10%)
|
3 |
1/62 (1.61%)
|
1 |
Laryngeal edema |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Nasal congestion |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pharyngeal mucositis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Pharyngolaryngeal pain |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
3/451 (0.67%)
|
3 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pleural effusion |
16/1563 (1.02%)
|
16 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
0/147 (0.00%)
|
0 |
4/451 (0.89%)
|
4 |
1/219 (0.46%)
|
2 |
10/285 (3.51%)
|
10 |
0/80 (0.00%)
|
0 |
5/143 (3.50%)
|
5 |
0/62 (0.00%)
|
0 |
Pleural hemorrhage |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pneumonitis |
7/1563 (0.45%)
|
7 |
0/368 (0.00%)
|
0 |
6/372 (1.61%)
|
6 |
2/147 (1.36%)
|
3 |
7/451 (1.55%)
|
7 |
2/219 (0.91%)
|
2 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
0/62 (0.00%)
|
0 |
Pneumothorax |
5/1563 (0.32%)
|
5 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pulmonary edema |
5/1563 (0.32%)
|
5 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Pulmonary fibrosis |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Respiratory failure |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
3/219 (1.37%)
|
3 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
2/143 (1.40%)
|
2 |
1/62 (1.61%)
|
1 |
Respiratory, thoracic and mediastinal disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
1/451 (0.22%)
|
1 |
2/219 (0.91%)
|
2 |
1/285 (0.35%)
|
1 |
1/80 (1.25%)
|
2 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Sore throat |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Stridor |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Wheezing |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
|
|
|
|
|
|
Erythema multiforme |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pain of skin |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Palmar-plantar erythrodysesthesia syndrome |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
2/451 (0.44%)
|
2 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Photosensitivity |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Pruritus |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
0/147 (0.00%)
|
0 |
7/451 (1.55%)
|
8 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Purpura |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Rash maculo-papular |
4/1563 (0.26%)
|
4 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
4 |
1/147 (0.68%)
|
1 |
9/451 (2.00%)
|
9 |
1/219 (0.46%)
|
2 |
1/285 (0.35%)
|
1 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
2/372 (0.54%)
|
2 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
4 |
3/219 (1.37%)
|
5 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Skin ulceration |
2/1563 (0.13%)
|
2 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
2/451 (0.44%)
|
2 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Stevens-Johnson syndrome |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Urticaria |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
4 |
2/147 (1.36%)
|
2 |
3/451 (0.67%)
|
3 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Social circumstances |
|
|
|
|
|
|
|
|
|
|
Social circumstances - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
1/62 (1.61%)
|
1 |
Surgical and medical procedures |
|
|
|
|
|
|
|
|
|
|
Surgical and medical procedures - Other, specify |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
1/372 (0.27%)
|
1 |
1/147 (0.68%)
|
1 |
0/451 (0.00%)
|
0 |
1/219 (0.46%)
|
1 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
|
|
|
|
|
|
Capillary leak syndrome |
0/1563 (0.00%)
|
0 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Hematoma |
3/1563 (0.19%)
|
3 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
0/451 (0.00%)
|
0 |
0/219 (0.00%)
|
0 |
0/285 (0.00%)
|
0 |
0/80 (0.00%)
|
0 |
1/143 (0.70%)
|
1 |
0/62 (0.00%)
|
0 |
Hypertension |
62/1563 (3.97%)
|
62 |
0/368 (0.00%)
|
0 |
4/372 (1.08%)
|
14 |
1/147 (0.68%)
|
1 |
10/451 (2.22%)
|
11 |
3/219 (1.37%)
|
4 |
8/285 (2.81%)
|
8 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Hypotension |
20/1563 (1.28%)
|
20 |
0/368 (0.00%)
|
0 |
14/372 (3.76%)
|
14 |
4/147 (2.72%)
|
4 |
10/451 (2.22%)
|
11 |
6/219 (2.74%)
|
6 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
10/143 (6.99%)
|
10 |
6/62 (9.68%)
|
7 |
Thromboembolic event |
25/1563 (1.60%)
|
25 |
0/368 (0.00%)
|
0 |
7/372 (1.88%)
|
7 |
1/147 (0.68%)
|
1 |
3/451 (0.67%)
|
3 |
3/219 (1.37%)
|
3 |
16/285 (5.61%)
|
16 |
0/80 (0.00%)
|
0 |
6/143 (4.20%)
|
6 |
2/62 (3.23%)
|
2 |
Vascular disorders - Other, specify |
1/1563 (0.06%)
|
1 |
0/368 (0.00%)
|
0 |
0/372 (0.00%)
|
0 |
0/147 (0.00%)
|
0 |
1/451 (0.22%)
|
1 |
0/219 (0.00%)
|
0 |
2/285 (0.70%)
|
2 |
0/80 (0.00%)
|
0 |
0/143 (0.00%)
|
0 |
0/62 (0.00%)
|
0 |
Term from vocabulary, CTCv4
Indicates events were collected by systematic assessment
|