Safety profile according to organ classes
Organ manifestations . | Symptoms . | No. of patients . | P value . | |
---|---|---|---|---|
Anagrelide group . | Hydroxyurea group . | |||
Infections and infestations | Herpes (simplex, labialis, zoster) | 1 | 4 | .37 |
Infections (viral, influenza-like symptoms) | 12 | 28 | .01 | |
Blood and lymphatic system disorders | Anemia | 11 | 24 | .04 |
Epistaxis | 6 | 15 | .07 | |
Leukopenia | 1 | 37 | < .01 | |
Nervous system disorders | Headache | 29 | 22 | .21 |
Vertigo | 6 | 14 | .10 | |
Ear and labyrinth disorders | Dizziness | 7 | 2 | .09 |
Cardiac disorders | Hypertension | 14 | 4 | .01 |
Palpitations | 30 | 3 | < .01 | |
Tachycardia | 13 | 3 | .01 | |
Respiratory, thoracic, and mediastinal disorders | Bronchitis | 3 | 8 | .22 |
Gastrointestinal disorders | Abdominal pain | 11 | 11 | 1.00 |
Diarrhea | 17 | 10 | .15 | |
Other gastrointestinal events | 11 | 14 | .83 | |
Skin and subcutaneous tissue disorders | Alopecia | 0 | 5 | .06 |
Skin disorders | 7 | 16 | .12 |
Organ manifestations . | Symptoms . | No. of patients . | P value . | |
---|---|---|---|---|
Anagrelide group . | Hydroxyurea group . | |||
Infections and infestations | Herpes (simplex, labialis, zoster) | 1 | 4 | .37 |
Infections (viral, influenza-like symptoms) | 12 | 28 | .01 | |
Blood and lymphatic system disorders | Anemia | 11 | 24 | .04 |
Epistaxis | 6 | 15 | .07 | |
Leukopenia | 1 | 37 | < .01 | |
Nervous system disorders | Headache | 29 | 22 | .21 |
Vertigo | 6 | 14 | .10 | |
Ear and labyrinth disorders | Dizziness | 7 | 2 | .09 |
Cardiac disorders | Hypertension | 14 | 4 | .01 |
Palpitations | 30 | 3 | < .01 | |
Tachycardia | 13 | 3 | .01 | |
Respiratory, thoracic, and mediastinal disorders | Bronchitis | 3 | 8 | .22 |
Gastrointestinal disorders | Abdominal pain | 11 | 11 | 1.00 |
Diarrhea | 17 | 10 | .15 | |
Other gastrointestinal events | 11 | 14 | .83 | |
Skin and subcutaneous tissue disorders | Alopecia | 0 | 5 | .06 |
Skin disorders | 7 | 16 | .12 |
Data are given as the number of patients experiencing at least once the adverse event described. Only adverse events occurring in more than 3% of patients in a treatment group were considered for comparison of the safety profile. For statistical analysis of adverse events, the Fisher exact test was used.