Table 3 New clinical and laboratory adverse events observed over 3 years

Clinical adverse events grade ≥ 3

82 ^*

 Grade 3: severe

45

(54.9)

 Grade 4: life threatening

8

(9.8)

 Grade 5: death^†

7

(8.5)

 Obstetrical/postpartum medical condition

22

(26.8)

Laboratory event grade ≥ 2

149ǂ

 Low hemoglobin

58

(38.9)

 Elevated alanine aminotransferase (ALT)

37

(24.8)

 Low absolute neutrophil count

18

(12.1)

 Low platelets

13

(8.7)

 Elevated bilirubin (total)

10

(6.7)

 Low Phosphate

6

(4.0)

 Low white Blood Cells (WBC)

4

(2.7)

 Low absolute lymphocyte count

3

(2.0)

 Elevated creatinine

0

(0.0)