Table 2. Incidence of grade 3 and 4 blood count and liver test adverse events within the first 10 days after initiating HCQ therapy in hospitalized patients with COVID-19.
| Lab value | No. Evaluable1 | Grade 3: No. (%) | Grade 4: No. (%) |
|---|---|---|---|
| Blood count abnormalities | |||
| Neutropenia2 | 136 | 3 (2.2%) | None |
| Lymphopenia3 | 125 | 13 (10.4%) | 2 (1.6%) |
| Anemia4 | 134 | 20 (14.9%) | None |
| Thrombocytopenia5 | 138 | None | 1 (0.7%) |
| Liver test abnormalities | |||
| AST elevation6 | 122 | 10 (8.2%) | 3 (2.5%) |
| ALT elevation6 | 123 | 8 (6.5%) | 2 (1.6%) |
| Alkaline phosphatase elevation6 | 123 | 2 (1.6%) | None |
| Total bilirubin elevation7 | 123 | 4 (3.3%) | None |
Grading scale based on the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase.
1Assessment for this adverse event was only evaluable in patients who: i) had a baseline laboratory value prior to HCQ initiation and between days 1–10 after initiating HCQ; and ii) did not have a laboratory value that corresponds to a Grade 3 or 4 adverse event on the day of HCQ initiation (blood counts only).
2Grades 3 and 4 neutropenia are defined as an absolute neutrophil count of 500–1000 and <500 (x109 cells/L), respectively.
3Grades 3 and 4 lymphopenia are defined as an absolute neutrophil count of 200–500 and <200 (x109 cells/L), respectively.
4Grade 3 anemia is defined as hemoglobin <8 g/dL or need for transfusion. Grade 4 anemia indicates life-threatening consequences where urgent intervention indicated.
5Grades 3 and 4 thrombocytopenia are defined as an absolute neutrophil count of 25–50 and <25 (x109/L), respectively.
6Grade 3 AST, ALT, and alkaline phosphatase elevations are defined as an increase >5–20 times the upper limit of normal (ULN) if baseline was normal or >5–20 times baseline if baseline was abnormal. Grade 4 AST and ALT elevations are defined as >20 times ULN if baseline was normal or >20 times baseline if baseline was abnormal.
7Grade 3 total bilirubin elevation is defined as an increase >3–10 times the upper limit of normal (ULN) if baseline was normal or >3–10 times baseline if baseline was abnormal. Grade 4 elevation is defined as >10 times ULN if baseline was normal or >10 times baseline if baseline was abnormal.