Time Frame |
Up to 5 years
|
Adverse Event Reporting Description |
Analysis includes only eligible patients who also received treatment. Adverse events that are possibly, probably or definitely related to study drug are reported.
|
|
Arm/Group Title
|
Arm 1: Azacitidine/Lenalidomide
|
Arm 2: Azacitidine
|
Arm 3: Azacitidine/Vorinostat
|
Arm/Group Description |
Patients receive azacitidine SC or ...
|
Patients receive azacitidine as in ...
|
Patients receive azacitidine as in ...
|
Arm/Group Description |
Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
|
Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
|
Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
|
|
|
Arm 1: Azacitidine/Lenalidomide
|
Arm 2: Azacitidine
|
Arm 3: Azacitidine/Vorinostat
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
--/-- |
--/-- |
--/-- |
|
|
Arm 1: Azacitidine/Lenalidomide
|
Arm 2: Azacitidine
|
Arm 3: Azacitidine/Vorinostat
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
37/89 (41.57%) |
8/91 (8.79%) |
47/91 (51.65%) |
Blood and lymphatic system disorders |
|
|
|
Anemia |
6/89 (6.74%) |
0/91 (0.00%) |
6/91 (6.59%) |
Blood and lymphatic system disorders - Other |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Febrile neutropenia |
6/89 (6.74%) |
1/91 (1.10%) |
2/91 (2.20%) |
Cardiac disorders |
|
|
|
Atrial fibrillation |
4/89 (4.49%) |
0/91 (0.00%) |
0/91 (0.00%) |
Atrioventricular block first degree |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Cardiac arrest |
1/89 (1.12%) |
1/91 (1.10%) |
0/91 (0.00%) |
Chest pain - cardiac |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Heart failure |
1/89 (1.12%) |
0/91 (0.00%) |
2/91 (2.20%) |
Myocardial infarction |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Pericardial effusion |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Sinus bradycardia |
2/89 (2.25%) |
0/91 (0.00%) |
2/91 (2.20%) |
Sinus tachycardia |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Ventricular arrhythmia |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Ventricular tachycardia |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Endocrine disorders |
|
|
|
Adrenal insufficiency |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Gastrointestinal disorders |
|
|
|
Abdominal pain |
0/89 (0.00%) |
0/91 (0.00%) |
5/91 (5.49%) |
Ascites |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Colitis |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Constipation |
1/89 (1.12%) |
0/91 (0.00%) |
2/91 (2.20%) |
Dental caries |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Dysphagia |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Enterocolitis |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Esophageal pain |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Gastric hemorrhage |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Gastrointestinal disorders-Other |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Gastrointestinal pain |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Ileus |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Jejunal hemorrhage |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Lower gastrointestinal hemorrhage |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Mucositis oral |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Nausea |
1/89 (1.12%) |
0/91 (0.00%) |
2/91 (2.20%) |
Small intestinal obstruction |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Upper gastrointestinal hemorrhage |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Vomiting |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
General disorders |
|
|
|
Death NOS |
0/89 (0.00%) |
1/91 (1.10%) |
0/91 (0.00%) |
Edema limbs |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Fatigue |
1/89 (1.12%) |
0/91 (0.00%) |
4/91 (4.40%) |
Fever |
1/89 (1.12%) |
0/91 (0.00%) |
6/91 (6.59%) |
Infusion related reaction |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Malaise |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Non-cardiac chest pain |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Pain |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Sudden death NOS |
0/89 (0.00%) |
1/91 (1.10%) |
0/91 (0.00%) |
Hepatobiliary disorders |
|
|
|
Cholecystitis |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Hepatobiliary disorders-Other |
2/89 (2.25%) |
0/91 (0.00%) |
0/91 (0.00%) |
Immune system disorders |
|
|
|
Allergic reaction |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Infections and infestations |
|
|
|
Abdominal infection |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Anorectal infection |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Bronchial infection |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Catheter related infection |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Infections and infestations-Other |
4/89 (4.49%) |
0/91 (0.00%) |
8/91 (8.79%) |
Lip infection |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Lung infection |
5/89 (5.62%) |
0/91 (0.00%) |
4/91 (4.40%) |
Mucosal infection |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Sepsis |
4/89 (4.49%) |
2/91 (2.20%) |
4/91 (4.40%) |
Skin infection |
2/89 (2.25%) |
0/91 (0.00%) |
1/91 (1.10%) |
Soft tissue infection |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Tooth infection |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Urinary tract infection |
0/89 (0.00%) |
1/91 (1.10%) |
3/91 (3.30%) |
Injury, poisoning and procedural complications |
|
|
|
Fracture |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Investigations |
|
|
|
Alanine aminotransferase increased |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Aspartate aminotransferase increased |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Blood bilirubin increased |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Cardiac troponin I increased |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Creatinine increased |
2/89 (2.25%) |
0/91 (0.00%) |
2/91 (2.20%) |
Investigations-Other |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Lymphocyte count increased |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Neutrophil count decreased |
2/89 (2.25%) |
0/91 (0.00%) |
4/91 (4.40%) |
Platelet count decreased |
7/89 (7.87%) |
0/91 (0.00%) |
8/91 (8.79%) |
White blood cell decreased |
3/89 (3.37%) |
0/91 (0.00%) |
2/91 (2.20%) |
Metabolism and nutrition disorders |
|
|
|
Anorexia |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Dehydration |
3/89 (3.37%) |
0/91 (0.00%) |
2/91 (2.20%) |
Hyperglycemia |
2/89 (2.25%) |
0/91 (0.00%) |
2/91 (2.20%) |
Hypoalbuminemia |
2/89 (2.25%) |
0/91 (0.00%) |
0/91 (0.00%) |
Hypocalcemia |
2/89 (2.25%) |
0/91 (0.00%) |
0/91 (0.00%) |
Hypokalemia |
4/89 (4.49%) |
0/91 (0.00%) |
0/91 (0.00%) |
Hypomagnesemia |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Hyponatremia |
4/89 (4.49%) |
0/91 (0.00%) |
2/91 (2.20%) |
Hypophosphatemia |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Metabolism and nutrition disorders - Other, specify |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Back pain |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Generalized muscle weakness |
2/89 (2.25%) |
0/91 (0.00%) |
3/91 (3.30%) |
Neck pain |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
|
|
Neoplasms benign, malignant and unspecified - Other |
2/89 (2.25%) |
0/91 (0.00%) |
0/91 (0.00%) |
Nervous system disorders |
|
|
|
Dizziness |
2/89 (2.25%) |
0/91 (0.00%) |
1/91 (1.10%) |
Headache |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Intracranial hemorrhage |
2/89 (2.25%) |
1/91 (1.10%) |
0/91 (0.00%) |
Nervous system disorders-Other |
0/89 (0.00%) |
1/91 (1.10%) |
0/91 (0.00%) |
Presyncope |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Stroke |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Syncope |
1/89 (1.12%) |
0/91 (0.00%) |
4/91 (4.40%) |
Psychiatric disorders |
|
|
|
Confusion |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Delirium |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Hallucinations |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Renal and urinary disorders |
|
|
|
Acute kidney injury |
2/89 (2.25%) |
0/91 (0.00%) |
1/91 (1.10%) |
Chronic kidney disease |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Hematuria |
1/89 (1.12%) |
0/91 (0.00%) |
2/91 (2.20%) |
Renal and urinary disorders-Other |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Renal calculi |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Adult respiratory distress syndrome |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Cough |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Dyspnea |
6/89 (6.74%) |
0/91 (0.00%) |
2/91 (2.20%) |
Epistaxis |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Hypoxia |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Laryngeal hemorrhage |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Pleural effusion |
0/89 (0.00%) |
0/91 (0.00%) |
2/91 (2.20%) |
Pneumonitis |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Pulmonary edema |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Resp, thoracic and mediastinal disorders - Other |
1/89 (1.12%) |
0/91 (0.00%) |
0/91 (0.00%) |
Respiratory failure |
1/89 (1.12%) |
0/91 (0.00%) |
2/91 (2.20%) |
Skin and subcutaneous tissue disorders |
|
|
|
Rash maculo-papular |
4/89 (4.49%) |
0/91 (0.00%) |
0/91 (0.00%) |
Skin and subcutaneous tissue disorders - Other |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Vascular disorders |
|
|
|
Flushing |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Hematoma |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Hypertension |
2/89 (2.25%) |
0/91 (0.00%) |
2/91 (2.20%) |
Hypotension |
3/89 (3.37%) |
0/91 (0.00%) |
3/91 (3.30%) |
Thromboembolic event |
1/89 (1.12%) |
0/91 (0.00%) |
1/91 (1.10%) |
Vascular disorders-Other |
0/89 (0.00%) |
0/91 (0.00%) |
1/91 (1.10%) |
Indicates events were collected by systematic assessment
Term from vocabulary, CTCAE (4.0)
|
|
Frequency Threshold for Reporting Other Adverse Events
|
5%
|
|
Arm 1: Azacitidine/Lenalidomide
|
Arm 2: Azacitidine
|
Arm 3: Azacitidine/Vorinostat
|
|
Affected / at Risk (%) |
Affected / at Risk (%) |
Affected / at Risk (%) |
Total |
88/89 (98.88%) |
89/91 (97.80%) |
91/91 (100.00%) |
Blood and lymphatic system disorders |
|
|
|
Anemia |
76/89 (85.39%) |
71/91 (78.02%) |
72/91 (79.12%) |
Febrile neutropenia |
13/89 (14.61%) |
14/91 (15.38%) |
13/91 (14.29%) |
Cardiac disorders |
|
|
|
Chest pain - cardiac |
3/89 (3.37%) |
2/91 (2.20%) |
6/91 (6.59%) |
Sinus tachycardia |
3/89 (3.37%) |
4/91 (4.40%) |
9/91 (9.89%) |
Gastrointestinal disorders |
|
|
|
Abdominal pain |
8/89 (8.99%) |
14/91 (15.38%) |
21/91 (23.08%) |
Constipation |
49/89 (55.06%) |
54/91 (59.34%) |
44/91 (48.35%) |
Diarrhea |
42/89 (47.19%) |
23/91 (25.27%) |
53/91 (58.24%) |
Dry mouth |
10/89 (11.24%) |
9/91 (9.89%) |
7/91 (7.69%) |
Dyspepsia |
4/89 (4.49%) |
13/91 (14.29%) |
7/91 (7.69%) |
Gastroesophageal reflux disease |
4/89 (4.49%) |
1/91 (1.10%) |
6/91 (6.59%) |
Hemorrhoids |
5/89 (5.62%) |
2/91 (2.20%) |
4/91 (4.40%) |
Mucositis oral |
15/89 (16.85%) |
7/91 (7.69%) |
10/91 (10.99%) |
Nausea |
38/89 (42.70%) |
42/91 (46.15%) |
61/91 (67.03%) |
Oral pain |
5/89 (5.62%) |
2/91 (2.20%) |
4/91 (4.40%) |
Vomiting |
18/89 (20.22%) |
18/91 (19.78%) |
36/91 (39.56%) |
General disorders |
|
|
|
Chills |
19/89 (21.35%) |
11/91 (12.09%) |
10/91 (10.99%) |
Edema limbs |
24/89 (26.97%) |
22/91 (24.18%) |
28/91 (30.77%) |
Fatigue |
74/89 (83.15%) |
69/91 (75.82%) |
74/91 (81.32%) |
Fever |
14/89 (15.73%) |
19/91 (20.88%) |
15/91 (16.48%) |
General disorders and admin site conditions - Other |
5/89 (5.62%) |
4/91 (4.40%) |
5/91 (5.49%) |
Injection site reaction |
22/89 (24.72%) |
19/91 (20.88%) |
18/91 (19.78%) |
Non-cardiac chest pain |
2/89 (2.25%) |
3/91 (3.30%) |
5/91 (5.49%) |
Pain |
14/89 (15.73%) |
10/91 (10.99%) |
10/91 (10.99%) |
Infections and infestations |
|
|
|
Infections and infestations-Other |
9/89 (10.11%) |
10/91 (10.99%) |
8/91 (8.79%) |
Lung infection |
2/89 (2.25%) |
6/91 (6.59%) |
5/91 (5.49%) |
Skin infection |
9/89 (10.11%) |
13/91 (14.29%) |
9/91 (9.89%) |
Upper respiratory infection |
5/89 (5.62%) |
6/91 (6.59%) |
4/91 (4.40%) |
Urinary tract infection |
8/89 (8.99%) |
2/91 (2.20%) |
3/91 (3.30%) |
Injury, poisoning and procedural complications |
|
|
|
Bruising |
25/89 (28.09%) |
24/91 (26.37%) |
18/91 (19.78%) |
Fall |
0/89 (0.00%) |
6/91 (6.59%) |
7/91 (7.69%) |
Injury, poison and procedural complications - Other |
2/89 (2.25%) |
5/91 (5.49%) |
0/91 (0.00%) |
Investigations |
|
|
|
Alanine aminotransferase increased |
18/89 (20.22%) |
16/91 (17.58%) |
17/91 (18.68%) |
Alkaline phosphatase increased |
17/89 (19.10%) |
16/91 (17.58%) |
13/91 (14.29%) |
Aspartate aminotransferase increased |
18/89 (20.22%) |
23/91 (25.27%) |
17/91 (18.68%) |
Blood bilirubin increased |
14/89 (15.73%) |
13/91 (14.29%) |
24/91 (26.37%) |
Creatinine increased |
21/89 (23.60%) |
26/91 (28.57%) |
25/91 (27.47%) |
INR increased |
4/89 (4.49%) |
5/91 (5.49%) |
3/91 (3.30%) |
Lymphocyte count decreased |
32/89 (35.96%) |
16/91 (17.58%) |
19/91 (20.88%) |
Neutrophil count decreased |
77/89 (86.52%) |
58/91 (63.74%) |
73/91 (80.22%) |
Platelet count decreased |
78/89 (87.64%) |
68/91 (74.73%) |
69/91 (75.82%) |
Weight loss |
22/89 (24.72%) |
15/91 (16.48%) |
19/91 (20.88%) |
White blood cell decreased |
66/89 (74.16%) |
52/91 (57.14%) |
60/91 (65.93%) |
Metabolism and nutrition disorders |
|
|
|
Anorexia |
39/89 (43.82%) |
31/91 (34.07%) |
45/91 (49.45%) |
Dehydration |
9/89 (10.11%) |
10/91 (10.99%) |
17/91 (18.68%) |
Hypercalcemia |
2/89 (2.25%) |
6/91 (6.59%) |
3/91 (3.30%) |
Hyperglycemia |
33/89 (37.08%) |
27/91 (29.67%) |
32/91 (35.16%) |
Hyperkalemia |
6/89 (6.74%) |
6/91 (6.59%) |
6/91 (6.59%) |
Hypermagnesemia |
3/89 (3.37%) |
7/91 (7.69%) |
5/91 (5.49%) |
Hypernatremia |
5/89 (5.62%) |
3/91 (3.30%) |
3/91 (3.30%) |
Hyperuricemia |
2/89 (2.25%) |
5/91 (5.49%) |
3/91 (3.30%) |
Hypoalbuminemia |
29/89 (32.58%) |
21/91 (23.08%) |
32/91 (35.16%) |
Hypocalcemia |
30/89 (33.71%) |
16/91 (17.58%) |
25/91 (27.47%) |
Hypokalemia |
40/89 (44.94%) |
15/91 (16.48%) |
19/91 (20.88%) |
Hypomagnesemia |
13/89 (14.61%) |
10/91 (10.99%) |
9/91 (9.89%) |
Hyponatremia |
23/89 (25.84%) |
22/91 (24.18%) |
34/91 (37.36%) |
Hypophosphatemia |
4/89 (4.49%) |
2/91 (2.20%) |
6/91 (6.59%) |
Musculoskeletal and connective tissue disorders |
|
|
|
Arthralgia |
15/89 (16.85%) |
11/91 (12.09%) |
7/91 (7.69%) |
Back pain |
16/89 (17.98%) |
18/91 (19.78%) |
14/91 (15.38%) |
Bone pain |
6/89 (6.74%) |
2/91 (2.20%) |
3/91 (3.30%) |
Generalized muscle weakness |
22/89 (24.72%) |
15/91 (16.48%) |
23/91 (25.27%) |
Musculoskeletal and connective tiss disorder - Other |
5/89 (5.62%) |
3/91 (3.30%) |
1/91 (1.10%) |
Myalgia |
16/89 (17.98%) |
12/91 (13.19%) |
6/91 (6.59%) |
Neck pain |
6/89 (6.74%) |
4/91 (4.40%) |
1/91 (1.10%) |
Pain in extremity |
19/89 (21.35%) |
16/91 (17.58%) |
12/91 (13.19%) |
Nervous system disorders |
|
|
|
Dizziness |
19/89 (21.35%) |
22/91 (24.18%) |
28/91 (30.77%) |
Dysgeusia |
11/89 (12.36%) |
11/91 (12.09%) |
16/91 (17.58%) |
Headache |
12/89 (13.48%) |
14/91 (15.38%) |
16/91 (17.58%) |
Paresthesia |
5/89 (5.62%) |
1/91 (1.10%) |
1/91 (1.10%) |
Peripheral sensory neuropathy |
9/89 (10.11%) |
10/91 (10.99%) |
8/91 (8.79%) |
Tremor |
5/89 (5.62%) |
3/91 (3.30%) |
2/91 (2.20%) |
Psychiatric disorders |
|
|
|
Anxiety |
15/89 (16.85%) |
13/91 (14.29%) |
6/91 (6.59%) |
Confusion |
3/89 (3.37%) |
5/91 (5.49%) |
4/91 (4.40%) |
Depression |
9/89 (10.11%) |
9/91 (9.89%) |
12/91 (13.19%) |
Insomnia |
18/89 (20.22%) |
15/91 (16.48%) |
14/91 (15.38%) |
Renal and urinary disorders |
|
|
|
Chronic kidney disease |
1/89 (1.12%) |
3/91 (3.30%) |
7/91 (7.69%) |
Proteinuria |
4/89 (4.49%) |
7/91 (7.69%) |
1/91 (1.10%) |
Urinary frequency |
5/89 (5.62%) |
2/91 (2.20%) |
2/91 (2.20%) |
Respiratory, thoracic and mediastinal disorders |
|
|
|
Allergic rhinitis |
7/89 (7.87%) |
5/91 (5.49%) |
5/91 (5.49%) |
Cough |
24/89 (26.97%) |
26/91 (28.57%) |
28/91 (30.77%) |
Dyspnea |
41/89 (46.07%) |
36/91 (39.56%) |
36/91 (39.56%) |
Epistaxis |
5/89 (5.62%) |
13/91 (14.29%) |
11/91 (12.09%) |
Nasal congestion |
3/89 (3.37%) |
4/91 (4.40%) |
6/91 (6.59%) |
Pleural effusion |
1/89 (1.12%) |
5/91 (5.49%) |
4/91 (4.40%) |
Postnasal drip |
7/89 (7.87%) |
1/91 (1.10%) |
1/91 (1.10%) |
Sore throat |
7/89 (7.87%) |
2/91 (2.20%) |
8/91 (8.79%) |
Skin and subcutaneous tissue disorders |
|
|
|
Alopecia |
4/89 (4.49%) |
3/91 (3.30%) |
11/91 (12.09%) |
Dry skin |
7/89 (7.87%) |
4/91 (4.40%) |
5/91 (5.49%) |
Hyperhidrosis |
4/89 (4.49%) |
4/91 (4.40%) |
7/91 (7.69%) |
Pruritus |
29/89 (32.58%) |
15/91 (16.48%) |
7/91 (7.69%) |
Purpura |
6/89 (6.74%) |
5/91 (5.49%) |
7/91 (7.69%) |
Rash maculo-papular |
46/89 (51.69%) |
20/91 (21.98%) |
16/91 (17.58%) |
Skin and subcutaneous tissue disorders - Other |
14/89 (15.73%) |
15/91 (16.48%) |
5/91 (5.49%) |
Skin ulceration |
4/89 (4.49%) |
1/91 (1.10%) |
6/91 (6.59%) |
Vascular disorders |
|
|
|
Hematoma |
5/89 (5.62%) |
4/91 (4.40%) |
5/91 (5.49%) |
Hot flashes |
9/89 (10.11%) |
4/91 (4.40%) |
5/91 (5.49%) |
Hypertension |
10/89 (11.24%) |
11/91 (12.09%) |
11/91 (12.09%) |
Hypotension |
13/89 (14.61%) |
5/91 (5.49%) |
15/91 (16.48%) |
Indicates events were collected by systematic assessment
Term from vocabulary, CTCAE (4.0)
|