Table 4 Frequency of the 106 infections classified as “confirmed OI” by the SAC. Opportunistic infections (OI) were classified as “confirmed OI” after the evaluation of the cases available in Pharmachild with full agreement between the Safety Adjudication Committee (SAC) and the list of provisional pathogens/presentations. Data are presented as per the MedDRA High Level and Preferred Term and sorted by frequencies in descending order
HLT-PT name | “Confirmed OI” N = 106 | Patients N = 93* |
|---|---|---|
Herpes viral infections | 72 (68%) | 64 (68.8%) |
Herpes zoster | 66 (91.6%) | |
Herpes ophthalmic | 2 (2.8%) | |
Ophthalmic herpes zoster | 2 (2.8%) | |
Herpes virus infection | 1 (1.4%) | |
Herpes zoster oticus | 1 (1.4%) | |
Tuberculous infections | 11 (10.4%) | 10 (10.8%) |
Pulmonary tuberculosis | 6 (54.5%) | |
Disseminated tuberculosis | 4 (36.4%) | |
Bone tuberculosis | 1 (9.1%) | |
Candidainfections | 9 (8.5%) | 9 (9.7%) |
Oral candidiasis | 4 (44.4%) | |
Candida pneumonia | 2 (22.2%) | |
Balanitis candida | 1 (11.1%) | |
Candida sepsis | 1 (11.1%) | |
Esophageal candidiasis | 1 (11.1%) | |
Papilloma viral infections | 4 (3.8%) | 2 (2.2%) |
Vulvovaginal human papilloma virus infection | 3 (75%) | |
Anogenital warts | 1 (25%) | |
Pneumocystisinfections | 4 (3.8%) | 4 (4.3%) |
Pneumocystis jirovecii pneumonia | 4 (100%) | |
Cytomegaloviral infections | 3 (2.8%) | 3 (3.2%) |
Cytomegalovirus mononucleosis | 1 (33.3%) | |
Cytomegalovirus viraemia | 1 (33.3%) | |
Pneumonia cytomegaloviral | 1 (33.3%) | |
Aspergillus infections | 1 (0.9%) | 1 (1.1%) |
Bronchopulmonary aspergillosis | 1 (100%) | |
Leprous infections | 1 (0.9%) | 1 (1.1%) |
Leprosy | 1 (100%) | |
Infections NEC | 1 (0.9%) | 1 (1.1%) |
Infection in an immunocompromised host | 1 (100%) |