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Table 2 Summary of the main safety findings

From: Safety and feasibility of apheresis to harvest and concentrate parasites from subjects with induced blood stage Plasmodium vivax infection

 

Subject 1

Subject 2

Subject 3

Subject 4

Total AEs

SAEs

0

0

0

0

0

AEs

20

13

15

20

68

AEs related to malaria

13

8

14

19

54

AEs related to apheresis

2

3

0

4

9

Max temp °C

40.2

38.8

40.2

39.6

N/A

Max malaria clinical score

8

1

2

7

N/A

Ibuprofen use

400 mg × 5

400 mg × 5

400 mg × 5

nil

N/A

Acetaminophen use

1 g × 4; 500 mg × 1

1 g × 2

1 g × 4

500 mg × 2; 1 g × 2

N/A

Peak ALT (IU/L)

111

118

47

80

N/A

Peak AST (IU/L)

83

57

42

44

N/A

Platelet Nadir (× 109/L)

119

98

99

75

N/A

Maximum drop in haemoglobin from baseline (g/L)

17

9

25

20

N/A

Lymphocyte Nadir (× 109/L)

0.33

0.43

0.58

0.75

N/A

Peak parasitaemia (parasites/mL)

15,943

35,156

64,243

44,431

N/A

  1. SAE serious adverse event, AE adverse event
  2. Summary of the main safety findings encountered during the study