Table 6 Frequency of adverse drug events (mild to moderate WHO grading) in the AS-AQ and AL drug arms from day 1 to day 28 (PP)
Adverse event | AS-AQ (%) | AL (%) | P-value* |
|---|---|---|---|
n = 98 | n = 115 | ||
Using PP populations | |||
Gastrointestinal tract | |||
Vomiting | 0 (0.0) | 1 (0.9) | 1.000 |
Nausea | 0 (0.0) | 1 (0.9) | 1.000 |
Anorexia | 3 (3.1) | 4 (3.5) | 1.000 |
Abdominal pain | 6 (6.1) | 2 (1.7) | 0.147 |
Diarrhea | 1 (1.0) | 3 (2.6) | 0.626 |
Neuropsychiatric | |||
Headache | 2 (2.0) | 1 (0.9) | 0.595 |
Difficulty in hearing | 0 (0.0) | 1 (0.9) | 1.000 |
Blood circulatory system | |||
Leucopenia | 2 (2.0) | 2 (1.7) | 1.000 |
Leucocytosis | 14 (14.3) | 20 (17.4) | 0.537 |
Lymphocytosis (%) | 19 (19.4) | 16 (13.9) | 0.283 |
Eosinophilia + basophilia (%) | 17 (17.3) | 7 (6.1) | 0.010** |
Granulocytopenia (%) | 20 (20.4) | 22 (19.1) | 0.815 |
Lymphocytosis (number) | 20 (20.4) | 17 (14.8) | 0.280 |
Eosinophilia + basophilia (number) | 9 (9.2) | 6 (5.2) | 0.259 |
Granulocytopenia (number) | 3 (3.1) | 3 (2.6) | 1.000 |
Granulocytosis (number) | 1 (1.0) | 3 (2.6) | 0.626 |
Erythropenia | 2 (2.0) | 2 (1.7) | 1.000 |
Erythrocytosis | 5 (5.1) | 8 (7.0) | 0.573 |
Low hemoglobin level (anemia) | 9 (9.2) | 10 (8.7) | 0.901 |
Low hematocrit | 13 (13.3) | 10 (8.7) | 0.284 |
Decrease in mean cell volume | 5 (5.1) | 5 (4.3) | 1.000 |
Decrease in mean cell hemoglobin | 5 (5.1) | 9 (7.8) | 0.424 |
Decrease in mean cell hemoglobin concentration | 5 (5.1) | 8 (7.0) | 0.573 |
Thrombocytopenia | 2 (2.0) | 3 (2.6) | 1.000 |
Thrombocytosis | 27 (27.6) | 38 (33.0) | 0.386 |
Liver function | |||
Increase in aspartate aminotransferase | 7 (7.1) | 13 (11.3) | 0.299 |
Increase in alanine aminotransferase | 7 (7.1) | 9 (7.8) | 0.805 |
Kidney function | |||
Increase in creatinine | 0 (0.0) | 1 (0.9) | 1.000 |
Cardiovascular system | |||
Decrease in heart rate | 1 (1.0) | 2 (1.7) | 1.000 |
Low systolic blood pressure | 0 (0.0) | 1 (0.9) | 1.000 |
High systolic blood pressure | 2 (2.0) | 6 (5.2) | 0.292 |
Low diastolic blood pressure | 0 (0.0) | 6 (5.2) | 0.032** |
High diastolic blood pressure | 4 (4.1) | 3 (2.6) | 0.706 |
Respiratory system | |||
Increase in respiratory rate | 1 (1.0) | 3 (2.6) | 0.626 |
Difficulty in breathing | 2 (2.0) | 0 (0.0) | 0.211 |
Others | |||
Fever | 16 (16.3) | 28 (24.3) | 0.150 |
Asthenia | 1 (1.0) | 3 (2.6) | 0.626 |
Catarrh | 1 (1.0) | 1 (0.9) | 1.000 |
Cough | 3 (3.1) | 10 (8.7) | 0.087 |
Splenomegaly | 0 (0.0) | 1 (0.9) | 1.000 |
Abnormal chest | 1 (1.0) | 0 (0.0) | 0.460 |
Skin rash | 0 (0.0) | 4 (3.5) | 0.126 |
Perioral dermatitis | 0 (0.0) | 1 (0.9) | 1.000 |
Rhinorrhea | 0 (0.0) | 1 (0.9) | 1.000 |
Overall prevalence | 83 (84.7) | 99 (86.1) | 0.774 |