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Table 7 Adverse events occurred up to week 48 in the ISS T-002 study

From: HIV-1 Tat immunization restores immune homeostasis and attacks the HAART-resistant blood HIV DNA: results of a randomized phase II exploratory clinical trial

 

Treatment groups

 

Tat 7.5 μg, 3x

Tat 7.5 μg, 5x

Tat 30 μg, 3x

Tat 30 μg, 5x

 

N

%

N

%

N

%

N

%

Total

Number of subjects in the safety population

43

 

44

 

40

 

41

 

168

Number of subjects with at least one adverse event

27

62.8

26

59.1

26

65.0

25

61.0

103

Serious adverse events

2

7.14

2

7.1

3

11.1

3

11.1

10

Non-Serious Adverse Events

26

92.9

26

92.9

24

88.9

24

88.9

100

Adverse Events leading to withdrawal

1

1.3

2

2.5

2

2.6

2

2.9

7

Deaths

0

 

0

 

0

 

0

 

0

Relationship with study medication

Certain

3

8.6

3

8.6

4

12.5

8

23.5

18

Probable

1

2.9

5

14.3

3

4.0

3

8.8

12

Possible

4

11.5

3

8.6

4

12.5

2

5.9

13

Unlikely

2

5.7

3

8.6

1

3.3

0

0.0

6

Unrelated

25

71.4

21

60.0

20

62.5

21

61.8

87

Severity

Mild

26

76.5

25

67.6

22

71.0

21

63.6

94

Moderate

6

17.6

8

21.6

7

22.6

9

27.3

30

Severe

2

5.9

4

10.8

2

6.4

3

9.1

11