Body System Adverse Reaction §
|
||||
Gastrointestinal disorders |
||||
Diarrhea |
34 |
3 |
10 |
0 |
Constipation |
16 |
0 |
12 |
1 |
Nausea |
12 |
0 |
30 |
0 |
Musculoskeletal and |
||||
connective tissue disorders |
||||
Musculoskeletal pain * |
33 |
1 |
23 |
3 |
Arthralgia |
22 |
1 |
10 |
0 |
Muscle spasms |
13 |
0 |
6 |
0 |
Respiratory , thoracic and |
||||
mediastinal disorders |
||||
Cough |
27 |
1 |
12 |
0 |
Injury , poisoning and |
||||
procedural complications |
||||
Infusion related reaction |
25 |
2 |
58 |
8 |
Vascular disorders |
||||
Hemorrhage * |
25 |
1 |
9 |
0 |
Hypertension * |
17 |
4 |
4 |
3 |
General disorders and |
||||
administration site conditions |
||||
Pyrexia |
19 |
2 |
26 |
1 |
Fatigue |
18 |
0 |
17 |
2 |
Peripheral edema |
12 |
0 |
7 |
0 |
Infections and infestations |
||||
Pneumonia * |
16 |
9 |
9 |
4 †
|
Upper respiratory tract |
14 |
1 |
6 |
0 |
infection |
||||
Skin infection * |
13 |
1 |
3 |
0 |
Urinary tract infection |
12 |
3 |
7 |
1 |
Nasopharyngitis |
12 |
0 |
3 |
0 |
Conjunctivitis |
11 |
0 |
2 |
0 |
Metabolism and nutrition |
||||
disorders |
||||
Hyperuricemia |
13 |
1 |
0 |
0 |
Cardiac disorders |
||||
Atrial fibrillation |
12 |
5 |
0 |
0 |
Psychiatric disorders |
||||
Insomnia |
12 |
0 |
4 |
0 |
The body system and individual ADR terms are sorted in descending frequency | ||||
order in the IMBRUVICA arm . | ||||
* Includes multiple ADR terms | ||||
†
Includes one event with a fatal outcome .
| ||||
E1912 : Adverse reactions described below in Table 9 reflect exposure to | ||||
IMBRUVICA + rituximab with a median duration of 34.3 months and exposure | ||||
to FCR with a median of 4.7 months in E1912 in patients with previously | ||||
untreated CLL / SLL who were 70 years or younger . |
Body System Adverse Reaction |
||||
General disorders and |
||||
administration site conditions |
||||
Fatigue |
80 |
2 |
78 |
3 |
Peripheral edema |
28 |
1 |
17 |
0 |
Pyrexia |
27 |
1 |
27 |
1 |
Pain |
23 |
2 |
8 |
0 |
Body System Adverse Reaction |
||||
Musculoskeletal and |
||||
connective tissue disorders |
||||
Musculoskeletal pain * |
61 |
5 |
35 |
2 |
Arthralgia |
41 |
5 |
10 |
1 |
Gastrointestinal disorders |
||||
Diarrhea |
53 |
4 |
27 |
1 |
Nausea |
40 |
1 |
64 |
1 |
Stomatitis * |
22 |
1 |
8 |
1 |
Abdominal pain * |
19 |
2 |
10 |
1 |
Vomiting |
18 |
2 |
28 |
0 |
Constipation |
17 |
0 |
32 |
0 |
Skin and subcutaneous tissue |
||||
disorders |
||||
Rash * |
49 |
4 |
29 |
5 |
Bruising * |
36 |
1 |
4 |
1 |
Vascular disorders |
||||
Hypertension * |
42 |
19 |
22 |
6 |
Hemorrhage * |
31 |
2 |
8 |
1 |
Nervous system disorders |
||||
Headache |
40 |
1 |
27 |
1 |
Dizziness |
21 |
1 |
13 |
1 |
Peripheral neuropathy * |
19 |
1 |
13 |
1 |
Respiratory , thoracic and |
||||
mediastinal disorders |
||||
Cough |
32 |
0 |
25 |
0 |
Dyspnea |
22 |
2 |
21 |
1 |
Infections and infestations Upper respiratory tract |
29 |
1 |
19 |
2 |
infection |
||||
Skin infection * |
16 |
1 |
3 |
1 |
Metabolism and nutrition disorders
Hyperuricemia
|
19 |
1 |
4 |
0 |
Decreased appetite |
15 |
0 |
20 |
1 |
Psychiatric disorders Insomnia |
16 |
1 |
19 |
1 |
The body system and individual ADR terms are sorted in descending frequency | ||||
order in the IMBRUVICA arm . | ||||
* Includes multiple ADR terms |
Hematology abnormalities Neutrophils decreased |
53 |
30 |
70 |
44 |
Platelets decreased |
43 |
7 |
69 |
25 |
Hemoglobin decreased |
26 |
0 |
51 |
2 |
Chemistry abnormalities Creatinine increased |
38 |
1 |
17 |
1 |
Bilirubin increased |
30 |
2 |
15 |
0 |
AST increased |
25 |
3 |
23 |
< 1 |
Based on laboratory measurements per IWCLL criteria |