Time Frame |
Performed at 2.5 years after the last patient enrolled; up to 4 years.
|
Adverse Event Reporting Description |
Patients who started treatment AND submitted at least one Adverse Events Form are included below.
|
|
Arm/Group Title
|
Arm A (Rituximab, Bendamustine Hydrochloride)
|
Arm B (Ibrutinib)
|
Arm C (Ibrutinib, Rituximab)
|
Arm B Crossover
|
Arm/Group Description |
Patients receive rituximab 375 mg/m...
|
Patients receive ibrutinib 420mg PO...
|
Patients receive ibrutinib as in Ar...
|
Arm A patients experiencing disease...
|
Arm/Group Description |
Patients receive rituximab 375 mg/m2 IV on day 0 of course 1 and ritixumab 500 mg/m2 IV on day 1 of courses 2-6. Patients receive bendamustine hydrochloride 90 mg/m2 IV over 30 minutes on days 1-2 of courses 1-6. Courses repeat every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm B.
|
Patients receive ibrutinib 420mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Patients receive ibrutinib as in Arm B. Patients receive rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of course 2 and on day 1 of courses 3-6. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm A patients experiencing disease progression crossover to Arm B.
|
|
|
Arm A (Rituximab, Bendamustine Hydrochloride)
|
Arm B (Ibrutinib)
|
Arm C (Ibrutinib, Rituximab)
|
Arm B Crossover
|
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Affected / at Risk (%) |
|
Total |
15/176 (8.52%)
|
|
24/180 (13.33%)
|
|
22/181 (12.15%)
|
|
2/27 (7.41%)
|
|
|
|
Arm A (Rituximab, Bendamustine Hydrochloride)
|
Arm B (Ibrutinib)
|
Arm C (Ibrutinib, Rituximab)
|
Arm B Crossover
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
87/176 (49.43%)
|
|
112/180 (62.22%)
|
|
108/181 (59.67%)
|
|
16/27 (59.26%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
Anemia |
6/176 (3.41%)
|
6 |
9/180 (5.00%)
|
13 |
6/181 (3.31%)
|
7 |
2/27 (7.41%)
|
4 |
Febrile neutropenia |
13/176 (7.39%)
|
14 |
3/180 (1.67%)
|
4 |
1/181 (0.55%)
|
1 |
2/27 (7.41%)
|
2 |
Leukocytosis |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
4 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
Atrial fibrillation |
2/176 (1.14%)
|
2 |
19/180 (10.56%)
|
23 |
8/181 (4.42%)
|
11 |
2/27 (7.41%)
|
4 |
Atrial flutter |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
1 |
1/27 (3.70%)
|
1 |
Atrioventricular block complete |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Atrioventricular block first degree |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Cardiac arrest |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Cardiac disorders - Other, specify |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Chest pain - cardiac |
1/176 (0.57%)
|
1 |
5/180 (2.78%)
|
6 |
3/181 (1.66%)
|
4 |
0/27 (0.00%)
|
0 |
Heart failure |
2/176 (1.14%)
|
2 |
5/180 (2.78%)
|
6 |
5/181 (2.76%)
|
6 |
1/27 (3.70%)
|
1 |
Myocardial infarction |
2/176 (1.14%)
|
2 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Palpitations |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Pericardial effusion |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
4 |
1/181 (0.55%)
|
1 |
1/27 (3.70%)
|
1 |
Pericardial tamponade |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Pericarditis |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Sick sinus syndrome |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Sinus bradycardia |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Tricuspid valve disease |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Ventricular arrhythmia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Ventricular tachycardia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
|
|
Hearing impaired |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
Cataract |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Eye disorders - Other, specify |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Gastrointestinal disorders |
|
|
|
|
Abdominal distension |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Abdominal pain |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
4 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Ascites |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Colitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Constipation |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Diarrhea |
2/176 (1.14%)
|
2 |
5/180 (2.78%)
|
6 |
6/181 (3.31%)
|
6 |
3/27 (11.11%)
|
3 |
Dyspepsia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
4 |
0/27 (0.00%)
|
0 |
Dysphagia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Enterocolitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Esophageal hemorrhage |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Flatulence |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Gastric hemorrhage |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Gastrointestinal disorders - Other, specify |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
2 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Ileus |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Mucositis oral |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Nausea |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Oral hemorrhage |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Pancreatitis |
0/176 (0.00%)
|
0 |
4/180 (2.22%)
|
5 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Small intestinal obstruction |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Vomiting |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
General disorders |
|
|
|
|
Chills |
3/176 (1.70%)
|
3 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Death NOS |
6/176 (3.41%)
|
6 |
8/180 (4.44%)
|
8 |
7/181 (3.87%)
|
7 |
1/27 (3.70%)
|
1 |
Edema face |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Edema limbs |
0/176 (0.00%)
|
0 |
4/180 (2.22%)
|
4 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Fatigue |
3/176 (1.70%)
|
3 |
4/180 (2.22%)
|
5 |
7/181 (3.87%)
|
7 |
0/27 (0.00%)
|
0 |
Fever |
16/176 (9.09%)
|
19 |
4/180 (2.22%)
|
4 |
7/181 (3.87%)
|
7 |
1/27 (3.70%)
|
1 |
Flu like symptoms |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Gait disturbance |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
General disorders and administration site conditions - Other, specify |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Infusion related reaction |
9/176 (5.11%)
|
10 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Multi-organ failure |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Non-cardiac chest pain |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Pain |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
2/27 (7.41%)
|
2 |
Sudden death NOS |
2/176 (1.14%)
|
2 |
5/180 (2.78%)
|
5 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Hepatobiliary disorders |
|
|
|
|
Cholecystitis |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Hepatobiliary disorders - Other, specify |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Immune system disorders |
|
|
|
|
Allergic reaction |
3/176 (1.70%)
|
3 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Anaphylaxis |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Cytokine release syndrome |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Immune system disorders - Other, specify |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
Abdominal infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Appendicitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Bladder infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Bone infection |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Bronchial infection |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Encephalitis infection |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Gallbladder infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Infections and infestations - Other, specify |
3/176 (1.70%)
|
3 |
4/180 (2.22%)
|
4 |
5/181 (2.76%)
|
5 |
1/27 (3.70%)
|
1 |
Joint infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Lung infection |
6/176 (3.41%)
|
6 |
8/180 (4.44%)
|
9 |
12/181 (6.63%)
|
17 |
1/27 (3.70%)
|
1 |
Meningitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Pharyngitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Sepsis |
8/176 (4.55%)
|
8 |
5/180 (2.78%)
|
5 |
8/181 (4.42%)
|
9 |
0/27 (0.00%)
|
0 |
Skin infection |
0/176 (0.00%)
|
0 |
6/180 (3.33%)
|
7 |
9/181 (4.97%)
|
9 |
0/27 (0.00%)
|
0 |
Upper respiratory infection |
2/176 (1.14%)
|
2 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Urinary tract infection |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
4/181 (2.21%)
|
4 |
1/27 (3.70%)
|
1 |
Wound infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
Bruising |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
6/181 (3.31%)
|
8 |
0/27 (0.00%)
|
0 |
Fall |
1/176 (0.57%)
|
1 |
4/180 (2.22%)
|
6 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Fracture |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Injury, poisoning and procedural complications - Other, specify |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Postoperative hemorrhage |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Seroma |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Spinal fracture |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Investigations |
|
|
|
|
Alanine aminotransferase increased |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Alkaline phosphatase increased |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Aspartate aminotransferase increased |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Blood bilirubin increased |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
CPK increased |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Cardiac troponin I increased |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Creatinine increased |
2/176 (1.14%)
|
2 |
2/180 (1.11%)
|
2 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Ejection fraction decreased |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Investigations - Other, specify |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Lymphocyte count decreased |
7/176 (3.98%)
|
13 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Lymphocyte count increased |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Neutrophil count decreased |
15/176 (8.52%)
|
17 |
10/180 (5.56%)
|
11 |
11/181 (6.08%)
|
16 |
1/27 (3.70%)
|
2 |
Platelet count decreased |
5/176 (2.84%)
|
6 |
3/180 (1.67%)
|
3 |
6/181 (3.31%)
|
6 |
1/27 (3.70%)
|
1 |
Weight gain |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
White blood cell decreased |
3/176 (1.70%)
|
3 |
0/180 (0.00%)
|
0 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Metabolism and nutrition disorders |
|
|
|
|
Anorexia |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Dehydration |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Hyperglycemia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hyperkalemia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hypernatremia |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Hyperuricemia |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hypoalbuminemia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Hypocalcemia |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Hypokalemia |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Hyponatremia |
1/176 (0.57%)
|
1 |
3/180 (1.67%)
|
3 |
5/181 (2.76%)
|
5 |
1/27 (3.70%)
|
1 |
Hypophosphatemia |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
2 |
Tumor lysis syndrome |
2/176 (1.14%)
|
2 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
Back pain |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Chest wall pain |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Flank pain |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Generalized muscle weakness |
1/176 (0.57%)
|
1 |
3/180 (1.67%)
|
3 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Muscle weakness left-sided |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Muscle weakness lower limb |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorder - Other, specify |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Myalgia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Neck pain |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
Leukemia secondary to oncology chemotherapy |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Myelodysplastic syndrome |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify |
16/176 (9.09%)
|
21 |
20/180 (11.11%)
|
33 |
28/181 (15.47%)
|
39 |
7/27 (25.93%)
|
10 |
Treatment related secondary malignancy |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Nervous system disorders |
|
|
|
|
Ataxia |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Cognitive disturbance |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Depressed level of consciousness |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Dizziness |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
2/181 (1.10%)
|
4 |
0/27 (0.00%)
|
0 |
Encephalopathy |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Headache |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Intracranial hemorrhage |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Lethargy |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Leukoencephalopathy |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Nervous system disorders - Other, specify |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Paresthesia |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Peripheral motor neuropathy |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Peripheral sensory neuropathy |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Presyncope |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Seizure |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Stroke |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
4/181 (2.21%)
|
4 |
0/27 (0.00%)
|
0 |
Syncope |
3/176 (1.70%)
|
3 |
2/180 (1.11%)
|
2 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Transient ischemic attacks |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
Confusion |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Delirium |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Psychiatric disorders - Other, specify |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
Acute kidney injury |
2/176 (1.14%)
|
2 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Chronic kidney disease |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Hematuria |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Renal and urinary disorders - Other, specify |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
2 |
1/27 (3.70%)
|
1 |
Urinary incontinence |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Urinary retention |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Urinary tract obstruction |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
|
Reproductive system and breast disorders - Other, specify |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
Adult respiratory distress syndrome |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Aspiration |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Bronchopulmonary hemorrhage |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Chylothorax |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Cough |
2/176 (1.14%)
|
2 |
2/180 (1.11%)
|
2 |
3/181 (1.66%)
|
5 |
0/27 (0.00%)
|
0 |
Dyspnea |
3/176 (1.70%)
|
3 |
6/180 (3.33%)
|
7 |
4/181 (2.21%)
|
4 |
0/27 (0.00%)
|
0 |
Epistaxis |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Hypoxia |
2/176 (1.14%)
|
2 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Pleural effusion |
4/176 (2.27%)
|
5 |
9/180 (5.00%)
|
10 |
3/181 (1.66%)
|
4 |
1/27 (3.70%)
|
1 |
Pneumonitis |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Pulmonary edema |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Pulmonary hypertension |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Respiratory failure |
3/176 (1.70%)
|
3 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders - Other, specify |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Sleep apnea |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Wheezing |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
Alopecia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Dry skin |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Pruritus |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Rash maculo-papular |
4/176 (2.27%)
|
5 |
3/180 (1.67%)
|
3 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders - Other, specify |
1/176 (0.57%)
|
1 |
4/180 (2.22%)
|
7 |
4/181 (2.21%)
|
4 |
0/27 (0.00%)
|
0 |
Surgical and medical procedures |
|
|
|
|
Surgical and medical procedures - Other, specify |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Vascular disorders |
|
|
|
|
Hematoma |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
3/181 (1.66%)
|
4 |
0/27 (0.00%)
|
0 |
Hypertension |
0/176 (0.00%)
|
0 |
6/180 (3.33%)
|
6 |
6/181 (3.31%)
|
6 |
1/27 (3.70%)
|
1 |
Hypotension |
6/176 (3.41%)
|
6 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Thromboembolic event |
3/176 (1.70%)
|
3 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
|
|
Frequency Threshold for Reporting Other Adverse Events
|
0%
|
|
Arm A (Rituximab, Bendamustine Hydrochloride)
|
Arm B (Ibrutinib)
|
Arm C (Ibrutinib, Rituximab)
|
Arm B Crossover
|
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Affected / at Risk (%) |
# Events
|
Total |
176/176 (100.00%)
|
|
180/180 (100.00%)
|
|
181/181 (100.00%)
|
|
26/27 (96.30%)
|
|
Blood and lymphatic system disorders |
|
|
|
|
Anemia |
148/176 (84.09%)
|
511 |
134/180 (74.44%)
|
743 |
131/181 (72.38%)
|
756 |
20/27 (74.07%)
|
118 |
Blood and lymphatic system disorders - Other, specify |
7/176 (3.98%)
|
15 |
7/180 (3.89%)
|
14 |
4/181 (2.21%)
|
11 |
1/27 (3.70%)
|
1 |
Bone marrow hypocellular |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hemolytic uremic syndrome |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Leukocytosis |
4/176 (2.27%)
|
4 |
15/180 (8.33%)
|
43 |
12/181 (6.63%)
|
23 |
2/27 (7.41%)
|
8 |
Lymph node pain |
2/176 (1.14%)
|
2 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Spleen disorder |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
7 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Thrombotic thrombocytopenic purpura |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Cardiac disorders |
|
|
|
|
Aortic valve disease |
2/176 (1.14%)
|
4 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Atrial fibrillation |
3/176 (1.70%)
|
3 |
18/180 (10.00%)
|
41 |
18/181 (9.94%)
|
45 |
4/27 (14.81%)
|
17 |
Atrial flutter |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
5/181 (2.76%)
|
6 |
0/27 (0.00%)
|
0 |
Cardiac disorders - Other, specify |
2/176 (1.14%)
|
2 |
2/180 (1.11%)
|
3 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Chest pain - cardiac |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
11 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Conduction disorder |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Heart failure |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
5 |
1/181 (0.55%)
|
3 |
1/27 (3.70%)
|
4 |
Left ventricular systolic dysfunction |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
6 |
0/27 (0.00%)
|
0 |
Myocardial infarction |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Palpitations |
0/176 (0.00%)
|
0 |
9/180 (5.00%)
|
15 |
7/181 (3.87%)
|
14 |
0/27 (0.00%)
|
0 |
Paroxysmal atrial tachycardia |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Pericardial effusion |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Pericarditis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
4 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Sick sinus syndrome |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Sinus bradycardia |
2/176 (1.14%)
|
2 |
3/180 (1.67%)
|
18 |
5/181 (2.76%)
|
7 |
1/27 (3.70%)
|
1 |
Sinus tachycardia |
3/176 (1.70%)
|
3 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Supraventricular tachycardia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Ear and labyrinth disorders |
|
|
|
|
Ear and labyrinth disorders - Other, specify |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Ear pain |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Hearing impaired |
2/176 (1.14%)
|
10 |
1/180 (0.56%)
|
10 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Middle ear inflammation |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Tinnitus |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
3 |
1/181 (0.55%)
|
15 |
0/27 (0.00%)
|
0 |
Vertigo |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Endocrine disorders |
|
|
|
|
Endocrine disorders - Other, specify |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hypothyroidism |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Eye disorders |
|
|
|
|
Blurred vision |
4/176 (2.27%)
|
4 |
5/180 (2.78%)
|
17 |
2/181 (1.10%)
|
9 |
2/27 (7.41%)
|
2 |
Cataract |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
6 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Conjunctivitis |
3/176 (1.70%)
|
3 |
1/180 (0.56%)
|
1 |
3/181 (1.66%)
|
4 |
0/27 (0.00%)
|
0 |
Dry eye |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
4/181 (2.21%)
|
14 |
1/27 (3.70%)
|
1 |
Eye disorders - Other, specify |
1/176 (0.57%)
|
1 |
3/180 (1.67%)
|
8 |
5/181 (2.76%)
|
7 |
1/27 (3.70%)
|
1 |
Floaters |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Glaucoma |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
6 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Photophobia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
5 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Retinopathy |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Scleral disorder |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Watering eyes |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
3/181 (1.66%)
|
7 |
1/27 (3.70%)
|
5 |
Gastrointestinal disorders |
|
|
|
|
Abdominal pain |
5/176 (2.84%)
|
6 |
19/180 (10.56%)
|
36 |
4/181 (2.21%)
|
4 |
0/27 (0.00%)
|
0 |
Anal hemorrhage |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Ascites |
3/176 (1.70%)
|
6 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Bloating |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
15 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Colitis |
2/176 (1.14%)
|
4 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Constipation |
33/176 (18.75%)
|
73 |
11/180 (6.11%)
|
42 |
28/181 (15.47%)
|
51 |
0/27 (0.00%)
|
0 |
Diarrhea |
57/176 (32.39%)
|
95 |
95/180 (52.78%)
|
410 |
98/181 (54.14%)
|
453 |
12/27 (44.44%)
|
58 |
Dry mouth |
5/176 (2.84%)
|
9 |
7/180 (3.89%)
|
37 |
9/181 (4.97%)
|
33 |
2/27 (7.41%)
|
2 |
Dyspepsia |
30/176 (17.05%)
|
71 |
55/180 (30.56%)
|
225 |
73/181 (40.33%)
|
311 |
8/27 (29.63%)
|
42 |
Dysphagia |
1/176 (0.57%)
|
1 |
3/180 (1.67%)
|
4 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Enterocolitis |
2/176 (1.14%)
|
2 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Esophageal pain |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
3 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Esophageal ulcer |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Esophagitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Fecal incontinence |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Flatulence |
2/176 (1.14%)
|
6 |
1/180 (0.56%)
|
4 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Gastric hemorrhage |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Gastritis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Gastroesophageal reflux disease |
0/176 (0.00%)
|
0 |
8/180 (4.44%)
|
26 |
7/181 (3.87%)
|
12 |
1/27 (3.70%)
|
5 |
Gastrointestinal disorders - Other, specify |
6/176 (3.41%)
|
21 |
9/180 (5.00%)
|
19 |
5/181 (2.76%)
|
10 |
0/27 (0.00%)
|
0 |
Gastrointestinal pain |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
8 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Gingival pain |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hemorrhoidal hemorrhage |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
6 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Lower gastrointestinal hemorrhage |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Mucositis oral |
11/176 (6.25%)
|
14 |
26/180 (14.44%)
|
79 |
17/181 (9.39%)
|
53 |
1/27 (3.70%)
|
1 |
Nausea |
62/176 (35.23%)
|
134 |
25/180 (13.89%)
|
65 |
35/181 (19.34%)
|
50 |
2/27 (7.41%)
|
3 |
Oral dysesthesia |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Oral hemorrhage |
1/176 (0.57%)
|
3 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Oral pain |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
6 |
4/181 (2.21%)
|
6 |
0/27 (0.00%)
|
0 |
Periodontal disease |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
6 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Rectal hemorrhage |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Rectal mucositis |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Salivary duct inflammation |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Stomach pain |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Toothache |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Upper gastrointestinal hemorrhage |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Vomiting |
14/176 (7.95%)
|
20 |
7/180 (3.89%)
|
9 |
15/181 (8.29%)
|
19 |
0/27 (0.00%)
|
0 |
General disorders |
|
|
|
|
Chills |
22/176 (12.50%)
|
27 |
2/180 (1.11%)
|
2 |
11/181 (6.08%)
|
13 |
0/27 (0.00%)
|
0 |
Edema face |
2/176 (1.14%)
|
3 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Edema limbs |
41/176 (23.30%)
|
76 |
89/180 (49.44%)
|
383 |
96/181 (53.04%)
|
420 |
8/27 (29.63%)
|
23 |
Fatigue |
158/176 (89.77%)
|
578 |
150/180 (83.33%)
|
1165 |
158/181 (87.29%)
|
1210 |
25/27 (92.59%)
|
167 |
Fever |
21/176 (11.93%)
|
24 |
5/180 (2.78%)
|
5 |
5/181 (2.76%)
|
5 |
0/27 (0.00%)
|
0 |
Flu like symptoms |
1/176 (0.57%)
|
1 |
4/180 (2.22%)
|
9 |
4/181 (2.21%)
|
5 |
0/27 (0.00%)
|
0 |
Gait disturbance |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
General disorders and administration site conditions - Other, specify |
3/176 (1.70%)
|
7 |
11/180 (6.11%)
|
23 |
13/181 (7.18%)
|
23 |
3/27 (11.11%)
|
4 |
Infusion related reaction |
73/176 (41.48%)
|
97 |
0/180 (0.00%)
|
0 |
24/181 (13.26%)
|
24 |
0/27 (0.00%)
|
0 |
Injection site reaction |
3/176 (1.70%)
|
7 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Localized edema |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
7 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Malaise |
4/176 (2.27%)
|
5 |
2/180 (1.11%)
|
5 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Non-cardiac chest pain |
3/176 (1.70%)
|
3 |
3/180 (1.67%)
|
3 |
6/181 (3.31%)
|
9 |
0/27 (0.00%)
|
0 |
Pain |
4/176 (2.27%)
|
4 |
3/180 (1.67%)
|
6 |
12/181 (6.63%)
|
17 |
1/27 (3.70%)
|
5 |
Hepatobiliary disorders |
|
|
|
|
Cholecystitis |
1/176 (0.57%)
|
5 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hepatobiliary disorders - Other, specify |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Immune system disorders |
|
|
|
|
Allergic reaction |
11/176 (6.25%)
|
12 |
5/180 (2.78%)
|
5 |
10/181 (5.52%)
|
18 |
1/27 (3.70%)
|
5 |
Autoimmune disorder |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Cytokine release syndrome |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Immune system disorders - Other, specify |
4/176 (2.27%)
|
7 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
1/27 (3.70%)
|
2 |
Serum sickness |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Infections and infestations |
|
|
|
|
Bronchial infection |
2/176 (1.14%)
|
2 |
3/180 (1.67%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Catheter related infection |
1/176 (0.57%)
|
3 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Duodenal infection |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Enterocolitis infectious |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Eye infection |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Hepatitis viral |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Infections and infestations - Other, specify |
7/176 (3.98%)
|
9 |
7/180 (3.89%)
|
12 |
13/181 (7.18%)
|
18 |
1/27 (3.70%)
|
1 |
Laryngitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Lung infection |
8/176 (4.55%)
|
11 |
5/180 (2.78%)
|
5 |
9/181 (4.97%)
|
9 |
1/27 (3.70%)
|
2 |
Lymph gland infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Mucosal infection |
3/176 (1.70%)
|
3 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Nail infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
4 |
0/27 (0.00%)
|
0 |
Otitis media |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Papulopustular rash |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
3 |
0/27 (0.00%)
|
0 |
Paronychia |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
2/181 (1.10%)
|
10 |
0/27 (0.00%)
|
0 |
Penile infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Pharyngitis |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Prostate infection |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Rhinitis infective |
1/176 (0.57%)
|
2 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Scrotal infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Sepsis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
1/181 (0.55%)
|
1 |
1/27 (3.70%)
|
1 |
Sinusitis |
4/176 (2.27%)
|
4 |
5/180 (2.78%)
|
12 |
1/181 (0.55%)
|
1 |
1/27 (3.70%)
|
1 |
Skin infection |
7/176 (3.98%)
|
8 |
7/180 (3.89%)
|
22 |
14/181 (7.73%)
|
19 |
1/27 (3.70%)
|
1 |
Soft tissue infection |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Tooth infection |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Upper respiratory infection |
9/176 (5.11%)
|
9 |
8/180 (4.44%)
|
10 |
14/181 (7.73%)
|
23 |
1/27 (3.70%)
|
1 |
Urinary tract infection |
6/176 (3.41%)
|
6 |
12/180 (6.67%)
|
13 |
9/181 (4.97%)
|
13 |
0/27 (0.00%)
|
0 |
Wound infection |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Injury, poisoning and procedural complications |
|
|
|
|
Ankle fracture |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Bruising |
24/176 (13.64%)
|
43 |
117/180 (65.00%)
|
724 |
114/181 (62.98%)
|
738 |
14/27 (51.85%)
|
68 |
Fall |
1/176 (0.57%)
|
1 |
7/180 (3.89%)
|
8 |
4/181 (2.21%)
|
6 |
0/27 (0.00%)
|
0 |
Fracture |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
1/181 (0.55%)
|
1 |
1/27 (3.70%)
|
1 |
Hip fracture |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Injury, poisoning and procedural complications - Other, specify |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Postoperative hemorrhage |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Wound complication |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Investigations |
|
|
|
|
Alanine aminotransferase increased |
5/176 (2.84%)
|
11 |
14/180 (7.78%)
|
30 |
6/181 (3.31%)
|
13 |
0/27 (0.00%)
|
0 |
Alkaline phosphatase increased |
6/176 (3.41%)
|
16 |
10/180 (5.56%)
|
27 |
9/181 (4.97%)
|
20 |
0/27 (0.00%)
|
0 |
Aspartate aminotransferase increased |
9/176 (5.11%)
|
21 |
16/180 (8.89%)
|
28 |
7/181 (3.87%)
|
12 |
0/27 (0.00%)
|
0 |
Blood bilirubin increased |
9/176 (5.11%)
|
27 |
21/180 (11.67%)
|
54 |
28/181 (15.47%)
|
119 |
1/27 (3.70%)
|
4 |
CD4 lymphocytes decreased |
2/176 (1.14%)
|
8 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Cardiac troponin I increased |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Creatinine increased |
14/176 (7.95%)
|
24 |
18/180 (10.00%)
|
74 |
23/181 (12.71%)
|
82 |
1/27 (3.70%)
|
1 |
Ejection fraction decreased |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
GGT increased |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Hemoglobin increased |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
4 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
INR increased |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Investigations - Other, specify |
6/176 (3.41%)
|
7 |
8/180 (4.44%)
|
13 |
8/181 (4.42%)
|
13 |
2/27 (7.41%)
|
4 |
Lymphocyte count decreased |
48/176 (27.27%)
|
232 |
12/180 (6.67%)
|
30 |
24/181 (13.26%)
|
62 |
7/27 (25.93%)
|
14 |
Lymphocyte count increased |
17/176 (9.66%)
|
22 |
42/180 (23.33%)
|
192 |
30/181 (16.57%)
|
80 |
10/27 (37.04%)
|
22 |
Neutrophil count decreased |
128/176 (72.73%)
|
356 |
61/180 (33.89%)
|
143 |
68/181 (37.57%)
|
178 |
14/27 (51.85%)
|
41 |
Platelet count decreased |
138/176 (78.41%)
|
490 |
129/180 (71.67%)
|
995 |
131/181 (72.38%)
|
956 |
19/27 (70.37%)
|
104 |
Urine output decreased |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Weight gain |
1/176 (0.57%)
|
2 |
4/180 (2.22%)
|
7 |
7/181 (3.87%)
|
23 |
0/27 (0.00%)
|
0 |
Weight loss |
13/176 (7.39%)
|
26 |
10/180 (5.56%)
|
25 |
14/181 (7.73%)
|
30 |
0/27 (0.00%)
|
0 |
White blood cell decreased |
54/176 (30.68%)
|
175 |
8/180 (4.44%)
|
12 |
17/181 (9.39%)
|
37 |
2/27 (7.41%)
|
2 |
Metabolism and nutrition disorders |
|
|
|
|
Alkalosis |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Anorexia |
25/176 (14.20%)
|
35 |
20/180 (11.11%)
|
49 |
23/181 (12.71%)
|
40 |
0/27 (0.00%)
|
0 |
Dehydration |
4/176 (2.27%)
|
4 |
1/180 (0.56%)
|
1 |
3/181 (1.66%)
|
6 |
0/27 (0.00%)
|
0 |
Glucose intolerance |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hypercalcemia |
4/176 (2.27%)
|
5 |
6/180 (3.33%)
|
9 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hyperglycemia |
13/176 (7.39%)
|
31 |
16/180 (8.89%)
|
37 |
10/181 (5.52%)
|
38 |
1/27 (3.70%)
|
4 |
Hyperkalemia |
6/176 (3.41%)
|
9 |
12/180 (6.67%)
|
25 |
7/181 (3.87%)
|
13 |
1/27 (3.70%)
|
2 |
Hypernatremia |
3/176 (1.70%)
|
3 |
0/180 (0.00%)
|
0 |
4/181 (2.21%)
|
6 |
0/27 (0.00%)
|
0 |
Hyperuricemia |
1/176 (0.57%)
|
1 |
8/180 (4.44%)
|
23 |
4/181 (2.21%)
|
6 |
0/27 (0.00%)
|
0 |
Hypoalbuminemia |
9/176 (5.11%)
|
9 |
11/180 (6.11%)
|
19 |
10/181 (5.52%)
|
24 |
1/27 (3.70%)
|
1 |
Hypocalcemia |
13/176 (7.39%)
|
17 |
9/180 (5.00%)
|
17 |
7/181 (3.87%)
|
8 |
0/27 (0.00%)
|
0 |
Hypoglycemia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
4 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Hypokalemia |
5/176 (2.84%)
|
6 |
6/180 (3.33%)
|
14 |
8/181 (4.42%)
|
13 |
2/27 (7.41%)
|
5 |
Hypomagnesemia |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
4 |
5/181 (2.76%)
|
11 |
0/27 (0.00%)
|
0 |
Hyponatremia |
9/176 (5.11%)
|
10 |
7/180 (3.89%)
|
11 |
12/181 (6.63%)
|
34 |
2/27 (7.41%)
|
2 |
Hypophosphatemia |
2/176 (1.14%)
|
2 |
2/180 (1.11%)
|
8 |
3/181 (1.66%)
|
4 |
1/27 (3.70%)
|
2 |
Metabolism and nutrition disorders - Other, specify |
6/176 (3.41%)
|
10 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Tumor lysis syndrome |
3/176 (1.70%)
|
4 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorders |
|
|
|
|
Arthralgia |
5/176 (2.84%)
|
7 |
22/180 (12.22%)
|
84 |
26/181 (14.36%)
|
79 |
2/27 (7.41%)
|
4 |
Arthritis |
0/176 (0.00%)
|
0 |
5/180 (2.78%)
|
8 |
2/181 (1.10%)
|
6 |
0/27 (0.00%)
|
0 |
Back pain |
5/176 (2.84%)
|
10 |
9/180 (5.00%)
|
16 |
10/181 (5.52%)
|
15 |
0/27 (0.00%)
|
0 |
Bone pain |
5/176 (2.84%)
|
5 |
2/180 (1.11%)
|
3 |
1/181 (0.55%)
|
2 |
1/27 (3.70%)
|
1 |
Chest wall pain |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Flank pain |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
5 |
0/27 (0.00%)
|
0 |
Generalized muscle weakness |
6/176 (3.41%)
|
7 |
4/180 (2.22%)
|
5 |
9/181 (4.97%)
|
22 |
1/27 (3.70%)
|
1 |
Joint effusion |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Joint range of motion decreased |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
1/27 (3.70%)
|
1 |
Muscle weakness lower limb |
1/176 (0.57%)
|
1 |
3/180 (1.67%)
|
5 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Muscle weakness right-sided |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
4 |
0/27 (0.00%)
|
0 |
Muscle weakness trunk |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Muscle weakness upper limb |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Musculoskeletal and connective tissue disorder - Other, specify |
3/176 (1.70%)
|
13 |
14/180 (7.78%)
|
51 |
14/181 (7.73%)
|
44 |
0/27 (0.00%)
|
0 |
Musculoskeletal deformity |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Myalgia |
9/176 (5.11%)
|
18 |
13/180 (7.22%)
|
49 |
25/181 (13.81%)
|
64 |
4/27 (14.81%)
|
7 |
Neck pain |
0/176 (0.00%)
|
0 |
4/180 (2.22%)
|
5 |
3/181 (1.66%)
|
7 |
0/27 (0.00%)
|
0 |
Pain in extremity |
6/176 (3.41%)
|
9 |
22/180 (12.22%)
|
37 |
16/181 (8.84%)
|
24 |
1/27 (3.70%)
|
3 |
Soft tissue necrosis lower limb |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify |
4/176 (2.27%)
|
7 |
5/180 (2.78%)
|
9 |
5/181 (2.76%)
|
11 |
1/27 (3.70%)
|
1 |
Nervous system disorders |
|
|
|
|
Ataxia |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Cognitive disturbance |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
4 |
0/27 (0.00%)
|
0 |
Concentration impairment |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
6 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Dizziness |
47/176 (26.70%)
|
86 |
70/180 (38.89%)
|
236 |
72/181 (39.78%)
|
248 |
10/27 (37.04%)
|
29 |
Dysesthesia |
1/176 (0.57%)
|
2 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
7 |
0/27 (0.00%)
|
0 |
Dysgeusia |
16/176 (9.09%)
|
30 |
7/180 (3.89%)
|
22 |
6/181 (3.31%)
|
10 |
0/27 (0.00%)
|
0 |
Encephalopathy |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Headache |
7/176 (3.98%)
|
22 |
16/180 (8.89%)
|
39 |
16/181 (8.84%)
|
27 |
1/27 (3.70%)
|
1 |
Hydrocephalus |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Intracranial hemorrhage |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Lethargy |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
3 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Memory impairment |
2/176 (1.14%)
|
2 |
4/180 (2.22%)
|
7 |
3/181 (1.66%)
|
12 |
1/27 (3.70%)
|
3 |
Movements involuntary |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
3 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Nervous system disorders - Other, specify |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
6 |
4/181 (2.21%)
|
6 |
0/27 (0.00%)
|
0 |
Neuralgia |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Nystagmus |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Paresthesia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
3 |
0/27 (0.00%)
|
0 |
Peripheral motor neuropathy |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
3 |
0/27 (0.00%)
|
0 |
Peripheral sensory neuropathy |
5/176 (2.84%)
|
5 |
9/180 (5.00%)
|
24 |
12/181 (6.63%)
|
31 |
1/27 (3.70%)
|
1 |
Presyncope |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
3 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Radiculitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Seizure |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Sinus pain |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Somnolence |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Spasticity |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
2/181 (1.10%)
|
13 |
0/27 (0.00%)
|
0 |
Stroke |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Syncope |
3/176 (1.70%)
|
3 |
3/180 (1.67%)
|
4 |
3/181 (1.66%)
|
5 |
0/27 (0.00%)
|
0 |
Transient ischemic attacks |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Tremor |
2/176 (1.14%)
|
2 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Psychiatric disorders |
|
|
|
|
Agitation |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Anxiety |
7/176 (3.98%)
|
14 |
3/180 (1.67%)
|
6 |
5/181 (2.76%)
|
9 |
0/27 (0.00%)
|
0 |
Confusion |
4/176 (2.27%)
|
4 |
5/180 (2.78%)
|
5 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Depression |
2/176 (1.14%)
|
8 |
5/180 (2.78%)
|
17 |
2/181 (1.10%)
|
5 |
0/27 (0.00%)
|
0 |
Insomnia |
3/176 (1.70%)
|
4 |
15/180 (8.33%)
|
35 |
8/181 (4.42%)
|
13 |
0/27 (0.00%)
|
0 |
Libido decreased |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Psychiatric disorders - Other, specify |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Restlessness |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Renal and urinary disorders |
|
|
|
|
Acute kidney injury |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Bladder spasm |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Chronic kidney disease |
3/176 (1.70%)
|
8 |
2/180 (1.11%)
|
5 |
6/181 (3.31%)
|
21 |
2/27 (7.41%)
|
2 |
Hematuria |
1/176 (0.57%)
|
1 |
10/180 (5.56%)
|
22 |
10/181 (5.52%)
|
18 |
1/27 (3.70%)
|
1 |
Proteinuria |
3/176 (1.70%)
|
3 |
2/180 (1.11%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Renal and urinary disorders - Other, specify |
1/176 (0.57%)
|
1 |
3/180 (1.67%)
|
5 |
4/181 (2.21%)
|
16 |
0/27 (0.00%)
|
0 |
Renal calculi |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
5 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Urinary frequency |
4/176 (2.27%)
|
5 |
1/180 (0.56%)
|
3 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Urinary incontinence |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Urinary retention |
2/176 (1.14%)
|
2 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
4 |
0/27 (0.00%)
|
0 |
Urinary tract pain |
2/176 (1.14%)
|
4 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
3 |
0/27 (0.00%)
|
0 |
Urinary urgency |
1/176 (0.57%)
|
3 |
1/180 (0.56%)
|
4 |
1/181 (0.55%)
|
2 |
0/27 (0.00%)
|
0 |
Reproductive system and breast disorders |
|
|
|
|
Erectile dysfunction |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Gynecomastia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Prostatic obstruction |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Reproductive system and breast disorders - Other, specify |
1/176 (0.57%)
|
4 |
1/180 (0.56%)
|
8 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Testicular pain |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders |
|
|
|
|
Allergic rhinitis |
1/176 (0.57%)
|
2 |
3/180 (1.67%)
|
9 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Apnea |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Aspiration |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Atelectasis |
2/176 (1.14%)
|
2 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Bronchial obstruction |
1/176 (0.57%)
|
1 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Bronchopulmonary hemorrhage |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Cough |
74/176 (42.05%)
|
153 |
98/180 (54.44%)
|
342 |
107/181 (59.12%)
|
492 |
16/27 (59.26%)
|
66 |
Dyspnea |
23/176 (13.07%)
|
39 |
22/180 (12.22%)
|
62 |
23/181 (12.71%)
|
45 |
0/27 (0.00%)
|
0 |
Epistaxis |
0/176 (0.00%)
|
0 |
5/180 (2.78%)
|
17 |
17/181 (9.39%)
|
47 |
1/27 (3.70%)
|
6 |
Hiccups |
2/176 (1.14%)
|
2 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
3 |
0/27 (0.00%)
|
0 |
Hoarseness |
2/176 (1.14%)
|
3 |
0/180 (0.00%)
|
0 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Hypoxia |
2/176 (1.14%)
|
2 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Laryngopharyngeal dysesthesia |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Nasal congestion |
1/176 (0.57%)
|
1 |
5/180 (2.78%)
|
7 |
4/181 (2.21%)
|
4 |
0/27 (0.00%)
|
0 |
Pleural effusion |
4/176 (2.27%)
|
7 |
4/180 (2.22%)
|
5 |
3/181 (1.66%)
|
3 |
0/27 (0.00%)
|
0 |
Pneumonitis |
1/176 (0.57%)
|
1 |
1/180 (0.56%)
|
1 |
3/181 (1.66%)
|
4 |
0/27 (0.00%)
|
0 |
Pneumothorax |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Postnasal drip |
1/176 (0.57%)
|
1 |
2/180 (1.11%)
|
3 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Productive cough |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Pulmonary edema |
2/176 (1.14%)
|
3 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Pulmonary fibrosis |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
2/181 (1.10%)
|
4 |
0/27 (0.00%)
|
0 |
Pulmonary hypertension |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Respiratory failure |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Respiratory, thoracic and mediastinal disorders - Other, specify |
4/176 (2.27%)
|
5 |
2/180 (1.11%)
|
2 |
4/181 (2.21%)
|
4 |
0/27 (0.00%)
|
0 |
Sinus disorder |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Sleep apnea |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
2 |
1/27 (3.70%)
|
3 |
Sore throat |
3/176 (1.70%)
|
3 |
3/180 (1.67%)
|
6 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Wheezing |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
2/181 (1.10%)
|
3 |
0/27 (0.00%)
|
0 |
Skin and subcutaneous tissue disorders |
|
|
|
|
Alopecia |
5/176 (2.84%)
|
7 |
6/180 (3.33%)
|
14 |
2/181 (1.10%)
|
7 |
2/27 (7.41%)
|
2 |
Bullous dermatitis |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Dry skin |
5/176 (2.84%)
|
7 |
8/180 (4.44%)
|
26 |
10/181 (5.52%)
|
27 |
1/27 (3.70%)
|
2 |
Erythema multiforme |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
2 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hyperhidrosis |
1/176 (0.57%)
|
1 |
3/180 (1.67%)
|
12 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Nail discoloration |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Nail loss |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
7 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Nail ridging |
0/176 (0.00%)
|
0 |
4/180 (2.22%)
|
7 |
6/181 (3.31%)
|
9 |
1/27 (3.70%)
|
1 |
Pain of skin |
3/176 (1.70%)
|
3 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Palmar-plantar erythrodysesthesia syndrome |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Periorbital edema |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Photosensitivity |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
5 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Pruritus |
6/176 (3.41%)
|
11 |
10/180 (5.56%)
|
16 |
12/181 (6.63%)
|
15 |
0/27 (0.00%)
|
0 |
Purpura |
0/176 (0.00%)
|
0 |
3/180 (1.67%)
|
11 |
7/181 (3.87%)
|
28 |
2/27 (7.41%)
|
3 |
Rash acneiform |
1/176 (0.57%)
|
2 |
4/180 (2.22%)
|
9 |
5/181 (2.76%)
|
8 |
0/27 (0.00%)
|
0 |
Rash maculo-papular |
57/176 (32.39%)
|
112 |
74/180 (41.11%)
|
271 |
72/181 (39.78%)
|
212 |
7/27 (25.93%)
|
16 |
Skin and subcutaneous tissue disorders - Other, specify |
11/176 (6.25%)
|
17 |
23/180 (12.78%)
|
86 |
18/181 (9.94%)
|
37 |
3/27 (11.11%)
|
5 |
Skin atrophy |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
12 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Skin hyperpigmentation |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Skin hypopigmentation |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
3 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Skin ulceration |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
2 |
2/181 (1.10%)
|
2 |
0/27 (0.00%)
|
0 |
Urticaria |
0/176 (0.00%)
|
0 |
1/180 (0.56%)
|
1 |
1/181 (0.55%)
|
5 |
0/27 (0.00%)
|
0 |
Social circumstances |
|
|
|
|
Social circumstances - Other, specify |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Surgical and medical procedures |
|
|
|
|
Surgical and medical procedures - Other, specify |
3/176 (1.70%)
|
3 |
2/180 (1.11%)
|
2 |
1/181 (0.55%)
|
1 |
1/27 (3.70%)
|
1 |
Vascular disorders |
|
|
|
|
Flushing |
2/176 (1.14%)
|
2 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Hematoma |
0/176 (0.00%)
|
0 |
2/180 (1.11%)
|
3 |
6/181 (3.31%)
|
12 |
1/27 (3.70%)
|
1 |
Hot flashes |
2/176 (1.14%)
|
3 |
3/180 (1.67%)
|
12 |
3/181 (1.66%)
|
7 |
1/27 (3.70%)
|
4 |
Hypertension |
81/176 (46.02%)
|
276 |
121/180 (67.22%)
|
1146 |
126/181 (69.61%)
|
1119 |
19/27 (70.37%)
|
133 |
Hypotension |
10/176 (5.68%)
|
11 |
0/180 (0.00%)
|
0 |
3/181 (1.66%)
|
4 |
0/27 (0.00%)
|
0 |
Phlebitis |
2/176 (1.14%)
|
2 |
1/180 (0.56%)
|
1 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Superficial thrombophlebitis |
2/176 (1.14%)
|
3 |
0/180 (0.00%)
|
0 |
0/181 (0.00%)
|
0 |
0/27 (0.00%)
|
0 |
Thromboembolic event |
3/176 (1.70%)
|
3 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Vascular disorders - Other, specify |
2/176 (1.14%)
|
3 |
3/180 (1.67%)
|
3 |
2/181 (1.10%)
|
4 |
0/27 (0.00%)
|
0 |
Vasculitis |
0/176 (0.00%)
|
0 |
0/180 (0.00%)
|
0 |
1/181 (0.55%)
|
1 |
0/27 (0.00%)
|
0 |
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
|