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Table 2 Baseline and outcome characteristics of TB patients receiving placebo in combination with TB drugs for 30 days

From: Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB

No.

Sex

Age

Months on ATT

prior to placebo

Dx

TB

drugs

regime

Smear

status

Liver size

in cm over normal

Erythrocyte

sedimentation rate (mm/h)

Lymphocytes (%)

Leukocytes

(× 109/L)

Hemoglobin

(g/L)

Body weight

(kg)

Total

bilirubin

(μmol/L)

ALT

(mM/h/ml)

      

before

after

before

after

before

after

before

after

before

after

before

after

before

after

before

after

before

after

1

M

22

1

1stDx

HRZSE

1

1

1

0

3

6

22

36

6.1

8.7

155

150

74

75

12.1

9.9

0.3

0.3

2

F

35

0

1stDx

HRZSE

3

3

1

0

22

41

8

10

8

14.1

75

80

45

45

8.8

8.8

0.4

0.6

3

M

40

0

1stDx

HRZSE

1

1

0

1

35

32

12

11

11.8

11.1

158

150

62

62

9.9

9.9

0.4

0.6

4

F

30

0

1stDx

HRZSE

1

1

0

1

8

10

21

16

7.2

7.4

126

120

69

69

8.8

14

0.2

0.6

5

M

20

0

1stDx

HRZSE

3

3

0

0

50

35

27

26

9.2

10.9

116

110

64

66

8.8

8.8

0.3

0.2

6

M

53

2

RTB

HRZSE

2

1

2

1

23

27

19

23

5.5

4.6

86

89

84

86

12.1

8.8

0.3

0.1

7

M

42

0

RTB

HRZSE

3

3

1

1

52

49

19

17

10

9.8

113

115

60

61

8.8

8.8

0.1

0.4

8

M

48

0

RTB

HRZSE

3

3

0

0

47

38

40

37

11

10.3

139

129

60

61

8.8

17.2

0.1

0.4

9

M

22

1

MDR

HRZSE

1

1

1

1

31

20

17

13

8.8

7.7

136

146

70

72

8.8

8.8

0.4

0.6

10

M

36

1

MDR

ZAPPtO

1

1

3

3

33

30

27

25

10.1

9.1

107

131

69

69

21

12.1

0.7

1.7

 

2/8

Mean

= 34.8

± 3.58

Median

= 35.5

Mean

= 0.5

± 0.7

Median

= 0

  

1.9

1.8

0.9

± 0.31

0.8

± 0.29

30.4

± 5.30

28.8

± 4.27

21.2 ±

8.9

21.4

± 9.7

8.77 ±

0.65

9.37 ±

0.80

121.1

± 8.64

122

± 7.69

65.7

± 3.25

66.6

± 3.39

10.79

± 1.21

10.71

± 0.90

0.32

± 0.05

0.55

± 0.14

      

P = 0.34

P = 0.68

P = 0.61

P = 0.91

P = 0.43

P = 0.79

P = 0.01

P = 0.96

P = 0.055

  1. TB drugs used in this arm are abbreviated as follows: Izoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E), Streptomycin (S), Amikacin (A), Para-aminosalicylic acid (P), Prothionamide (Pt), Ofloxacin (O)