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Table 3 Incidence of related adverse events by system organ class and relationship to study treatment

From: HIV-Tat immunization induces cross-clade neutralizing antibodies and CD4+ T cell increases in antiretroviral-treated South African volunteers: a randomized phase II clinical trial

MedDRA system organ class

Treatment group

Tat vaccine

Placebo

Total

Relateda

Not relatedb

Relateda

Not relatedb

n

(m)

%

n

(m)

%

n

(m)

%

n

(m)

%

n

(m)

%

Number of subjects

100

  

100

  

100

  

100

  

200

  

Number of subjects with at least one adverse event

77

(621)

77.0

85

(262)

85.0

72

(344)

72.0

81

(237)

81.0

190

(1464)

95.0

General disorders and administration site conditions

73

(520)

73.0

8

(10)

8.0

58

(199)

58.0

11

(12)

11.0

133

(741)

66.5

Infections and infestations

1

(1)

1.0

50

(77)

50.0

2

(2)

2.0

56

(88)

56.0

107

(168)

53.5

Nervous system disorders

27

(40)

27.0

19

(24)

19.0

38

(67)

38.0

10

(13)

10.0

81

(144)

40.5

Musculoskeletal and connective tissue disorders

16

(25)

16.0

14

(16)

14.0

17

(31)

17.0

15

(28)

15.0

54

(100)

27.0

Gastrointestinal disorders

9

(12)

9.0

20

(25)

20.0

14

(18)

14.0

13

(19)

13.0

49

(74)

24.5

Skin and subcutaneous tissue disorders

10

(12)

10.0

15

(15)

15.0

10

(18)

10.0

13

(16)

13.0

47

(61)

23.5

Reproductive system and breast disorders

0

(0)

 

22

(24)

22.0

0

(0)

 

22

(27)

22.0

44

(51)

22.0

Investigations

2

(3)

2.0

19

(28)

19.0

2

(2)

2.0

8

(10)

8.0

30

(43)

15.0

Blood and lymphatic system disorders

7

(7)

7.0

7

(9)

7.0

5

(6)

5.0

3

(3)

3.0

21

(25)

10.5

Injury, poisoning and procedural complications

0

(0)

 

10

(12)

10.0

0

(0)

 

5

(7)

5.0

15

(19)

7.5

Vascular disorders

1

(1)

1.0

6

(6)

6.0

0

(0)

 

3

(3)

3.0

10

(10)

5.0

Respiratory, thoracic and mediastinal disorders

0

(0)

 

2

(2)

2.0

0

(0)

 

4

(5)

4.0

6

(7)

3.0

Eye disorders

0

(0)

 

3

(3)

3.0

0

(0)

 

2

(2)

2.0

5

(5)

2.5

Metabolism and nutrition disorders

0

(0)

 

3

(3)

3.0

0

(0)

 

1

(1)

1.0

4

(4)

2.0

Renal and urinary disorders

0

(0)

 

2

(2)

2.0

0

(0)

 

1

(1)

1.0

3

(3)

1.5

Surgical and medical procedures

0

(0)

 

2

(2)

2.0

0

(0)

 

1

(1)

1.0

3

(3)

1.5

Psychiatric disorders

0

(0)

 

2

(4)

2.0

0

(0)

 

0

(0)

 

2

(4)

1.0

Cardiac disorders

0

(0)

 

0

(0)

 

1

(1)

1.0

0

(0)

 

1

(1)

0.5

Immune system disorders

0

(0)

 

0

(0)

 

0

(0)

 

1

(1)

1.0

1

(1)

0.5

  1. n = number of subjects, (m) = number of mentions, % = all percentages are expressed as the percentage of subjects in the safety population in each treatment group. Adverse event data were coded using the MedDRA dictionary version 15.0
  2. aRelated refers to events whose relationship to the study treatment was regarded as certain, probable or possible
  3. bNot related refers to events whose relationship to the study treatment was regarded as unrelated or unlikely related
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Retrovirology

ISSN: 1742-4690

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