Diagnosis and Management of Infantile Hemangioma

Table H-3: Adverse Events from Flo-pred® Bioequivalence Studies 21
Study #
Dosage form
1 1 1 2 2 2 3 3 3
Suspension
(n=24)
Syrup
(n=24)
Arthralgia 0 0
Tablet
(n=24)
1
(4%)
Suspension
(n=24)
Headache 1 (4%) 0 0 3 (13%)
Somnolence 0
Dyspepsia 1 (4%)
1
(4%)
1
(4%)
Syrup
(n=23)
0 0
1
(4%)
Tablet
(n=24)
1
(4%)
6
(25%)
Suspension
(n=24)
Syrup
(n=23)
0 0
1 (4%)
1
(4%)
0 1 (4%) 0 0 0 0
1
(4%)
1 (4%)
1
(4%)
Fatigue 1 (4%) 0 0 1 (4%) 0
Tablet
(n=23)
1
(4%)
1
(4%)
1
(4%)
0 --- --- ---
1
(4%)
--- --- ---
1
1
Hot Flash 0
0 1 (4%)
0 --- --- --
(4%)
(4%)
Venipuncture site
1
1
1 (4%) 0
0
0 --- --- ---
pain
(4%)
(4%)
Lymphocyte count
2 2
1 1
2 (8%)
1 (4%)
--- --- ---
increased
(8%) (8%)
(4%) (4%)
Neutrophil count
1 1
2 2
1 (4%)
--- --- --- 2 (8%)
decreased
(4%) (4%)
(9%) (9%)
Ocular
1
1
--- --- --- 1 (4%) 0
0 0
hyperaemia
(4%)
(4%)
1
1
Lip dry --- --- --- 1 (4%)
0 0 0
(4%)
(4%)
1 1
Nausea --- --- --- 2 (8%)
1 (4%) 0 0
(4%) (4%)
1
1
Dizziness --- --- --- 1 (4%)
0 0
0
(4%)
(4%)
Venipuncture site
1 (4%) 0 0 --- --- --- --- --- ---
swelling
Blood Bilirubin
1 1
1 (4%)
--- --- --- --- --- ---
increase
(4%) (4%)
1
Increased appetite 0 0
--- --- --- --- --- ---
(4%)
Pharyngolaryngeal
1
0 0
--- --- --- --- --- ---
Pain
(4%)
Blister 1 (4%) 0 0
Abdominal
1
--- --- --- 0 0
--- --- ---
distension
(4%)
1
Abdominal pain --- --- --- 0 0
--- --- ---
(4%)
Upper abdominal
1
--- --- --- 0 0
--- --- ---
pain
(4%)
1
Diarrhea --- --- --- 0 0
--- --- --
(4%)
Dry mouth --- --- --- 1 (4%) 0 0 --- --- ---
Flatulence --- --- --- 1 (4%) 0 0 --- --- ---
1
Vomiting --- --- --- 1 (4%) 0
--- --- ---
(4%)
Vessel puncture
site bruise
--- --- --- 1 (4%) 0 0 --- --- ---
Tremor --- --- --- 1 (4%) 0 0 --- --- ---
Metrorrhagia --- --- --- 1 (4%) 0 0 --- --- ---
Nasal congestion --- --- --- 0 0
1
(4%)
--- --- ---
Rhinorrhea --- --- --- 0 0
1
(4%)
--- --- ---
H-15