en reported. [see Clinical Studies (14)]
Table 1 - Adverse Reactions in >10% of Patients on Vandetanib During Randomized Treatment
Preferred Term Vandetanib 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.
†
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.
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
Dry Skin
35 (15%)
0 5 (5%) 0
Vomiting
34 (15%)
2 (1%)
7 (7%)
0
Asthensia
34 (15%)
6 (3%)
11 (11%)
1 (1%)
ECG QT Prolonged‡
33 (14%)
18 (8%)
1 (1%)
1 (1%)
Photosensitivity Reaction
31 (13%)
4 (2%)
0
0
Insomnia
30 (13%)
0
10 (10%)
0
Nasopharyngitis
26 (11%)
0
10 (10%)
0
Dyspepsia
25 (11%)
0
4 (4%)
0
Hypocalcemia
25 (11%)
4 (2%)
3 (3%) 0
Cough
25 (11%)
0
10 (10%)
0
Pruritus
25 (11%)
3 (1%)
4 (4%)
0
Weight Decreased
24 (10%)
2 (1%)
9 (9%)
0
Proteinuria
23 (10%)
0
2 (2%)
0
Depression
22 (10%)
4 (2%)
3 (3%)
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 Vandetanib (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%) a