-off could receive open label CAPRELSA. The following adverse reactions have been reported. [see Clinical Studies (14)]
Table 1 - Adverse Reactions in >10% of Patients on CAPRELSA During Randomized Treatment
|
Preferred Term |
CAPRELSA 300 mg N=231 |
Placebo N=99 |
|
Includes rash, rash erythematous, generalized, macular, maculo-papular, papular, pruritic, exfoliative, dermatitis, dermatitis bullous, generalized erythema and eczema.
|
|
|
All Grades
|
Grade 3–4
|
All Grades
|
Grade 3–4
|
|
Diarrhea/Colitis
|
132 (57%)
|
26 (11%)
|
27 (27%)
|
2 (2%)
|
|
Rash*
|
123 (53%)
|
11 (5%)
|
12 (12%)
|
0
|
|
Dermatitis Acneiform/Acne
|
81 (35%)
|
2 (1%)
|
7 (7%)
|
0
|
|
Nausea
|
77 (33%)
|
2 (1%)
|
16 (16%)
|
0
|
|
Hypertension/Hypertensive Crisis/Accelerated Hypertension
|
76 (33%)
|
20 (9%)
|
5 (5%)
|
1 (1%)
|
|
Headache
|
59 (26%)
|
2 (1%)
|
9 (9%)
|
0
|
|
Fatigue
|
55 (24%)
|
13 (6%)
|
23 (23%)
|
1 (1%)
|
|
Decreased Appetite
|
49 (21%)
|
10 (4%)
|
12 (12%)
|
0
|
|
Abdominal Pain
|
48 (21%)
|
6 (3%)
|
11 (11%)
|
0
|
Includes rash, rash erythematous, generalized, macular, maculo-papular, papular, pruritic, exfoliative, dermatitis, dermatitis bullous, generalized erythema and eczema.
Includes abdominal pain, abdominal pain upper, lower abdominal pain and abdominal discomfort
69% had QT prolongation >450ms and 7% had QT prolongation >500ms by ECG using Fridericia correction.
Adverse reactions resulting in death in patients receiving CAPRELSA (N=5) were respiratory failure, respiratory arrest, aspiration pneumonia, cardiac failure with arrhythmia, and sepsis. Adverse reactions resulting in death in patients receiving placebo were gastrointestinal hemorrhage (1%) and gastroenteritis (1%). In addition there was one sudden death and one death from cardiopulmonary arrest, |
