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Table 5 Frequency of the “confirmed non-OI” and “possible/patient and pathogen-related OI” adjudicated by the SAC

From: Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee

HLT-PT name

N(%)

“Confirmed non-OI”

N = 59 (%)

“Possible/patient and pathogen-related OI”

N = 299 (%)

Herpes viral infections,N = 193 (64.5)

 Varicella

 

128 (42.8)

 Oral herpes

 

30 (10.1)

 Varicella zoster virus infection

 

24 (8.1)

 Other herpes infections

 

11 (3.7)

Epstein-Barr viral infections,N = 38 (12.7)

 Epstein-Barr virus infection

 

22 (7.4)

 Other EBV infections

 

16 (5.3)

Tuberculous infections,N = 18 (6.0)

 Latent tuberculosis

 

12 (4.1)

 Tuberculosis

 

6 (2.0)

Candidainfections,N = 8 (2.7)

 Vulvovaginal candidiasis

 

6 (2.1)

 Other candidiasis

 

2 (0.6)

Influenza viral infections,N = 14 (23.7)

 Influenza

13 (22)

 

 H1N1 influenza

1 (1.7)

 

Streptococcal infections,N = 14 (23.7)

 Scarlet fever

4 (6.7)

 

 Pharyngitis streptococcal

3 (5.1)

 

 Other streptococcal infections

7 (11.9)

 

Salmonellainfections,N = 9 (3.0)

 Gastroenteritis salmonella

 

6 (2.1)

 Other Salmonella infections

 

3 (1.0)

Molluscum contagiosum viral infections,N = 7(2.3) (2.3)

 Molluscum contagiosum

 

7 (2.3)

Staphylococcal infections,N = 5 (8.5)

 Staphylococcal sepsis

2 (3.4)

 

 Other staphylococcal infections

3 (5.1)

 

Escherichia infections,N = 4 (6.8)

Escherichia pyelonephritis

3 (5.1)

 

 Cystitis Escherichia

1 (1.7)

 

Skin structures and soft tissue infections,N = 3 (5.1) (5.1)

 Impetigo

3 (5.1)

 

Bordetella infections, N = 3 (5.1)

 Pertussis

2 (3.4)

 

Bordetella infection

1 (1.7)

 

Mycoplasma infections, N = 3 (5.1)

Mycoplasma infections

3 (5.1)

 

Yersinia infections, N = 2 (3.4)

 Gastroenteritis yersinia

2 (3.4)

 

Other infections (HLT frequency < 2%)

11 (18.6)

26 (8.7)

  1. Clinical presentations were removed because of the lack of the specified pathogen. Data are presented as per the MedDRA High Level Term and Preferred Term and sorted by frequencies in descending order. Only pathogens with HLT % ≥ 2% are presented in details. The full listing is available in additional table 1. SAC Safety Adjudication Committee