Table 3.
Hematologic and biochemical alterations during follow-up
| Parametera | No. (%) of alterations during follow-up |
No. of patients with severe clinical ADRs and hematologic alterations | |||
|---|---|---|---|---|---|
| Day 15 | Day 30 | Day 45 | Day 60 | ||
| Complete blood count | |||||
| RBC* | 6 (13) | 12 (29) | 15 (38) | 14 (33) | 0 |
| WBC* | |||||
| Leukopenia | 3 (7) | 3 (7) | 1 (3) | 2 (5) | 0 |
| Neutropenia | 7 (15) | 11 (26) | 14 (35) | 10 (24) | 0 |
| Lymphopeniab | 2 (4)c | 3 (7) | 3 (8) | 1 (2) | 1 |
| Eosinophiliac | |||||
| Mild | 7 (15) | 7 (17) | 5 (13) | 11 (26) | 1 |
| Moderate | 5(11) | 1 (2) | 3 (8) | 2 (4)c | |
| Biochemistry | |||||
| Transaminases* | 8 (17)d | 9 (21) | 10 (24) | 9 (21) | 0 |
| Bilirubin* | 1 (2) | 2 (5) | 1 (2) | 0 | |
| LDH* | 4 (9) | 3 (7) | 3 (7) | 5 (12) | 1 |
| Total proteins* | 2 (4) | 3 (7) | 1 (2) | 1 | |
a
RBC, red blood cells; WBC, white blood cells; LDH, lactate dehydrogenase. *, Mild alterations: anemia (hemoglobin, 10 to 12 mg/dl), leukopenia (3,000 to 35,000 WBC/ml), neutropenia (1,000 to 1,200 neutrophils/ml, transaminases (<3 × ULN), bilirubin (0.2 to 1.2 mg/dl), LDH (250 to 450 U/liter), and total proteins (63 to 80 g/liter). Eosinophilia was mild (500 to 999 eosinophils/ml) or moderate (1,000 to 3,000 eosinophils/ml).
b
All cases were moderate (500 to 1,000 lymphocytes/ml), except for one severe case (<500 lymphocytes/ml).
c
There was one case of severe eosinophilia (>3,000 eosinophils/ml).
d
In one case, more than ×3 ULN.