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