| MVC (QD+BID) [N = 840]: exposure adjusted incidence*, unadjusted incidence (%) | Placebo [N = 209]: exposure adjusted incidence*, unadjusted incidence (%) | Risk Ratio (exposure adjusted): MVC/PBO (95% CI) |
---|---|---|---|
Infections and infestations among sentinel infections/Category C illnesses | 27.04, 159 (18.93) | 31.37, 33 (15.79) | 0.86 (0.59, 1.25) |
Selected Category C infections | Â | Â | Â |
Herpes simplex | 4, 24 (2.86) | 1.8, 2 (0.96) | 2.22 (0.53, 9.40) |
Oesophageal Candidiasis | 2.5, 15 (1.79) | 1.8, 2 (0.96) | 1.39 (0.32, 6.07) |
Oral Candidiasis | 4.7, 28 (3.33) | 7.4, 8 (3.83) | 0.64 (0.29, 1.39) |
Infections and infestations among adverse events | 92.80, 447 (53.21) | 132.90, 84 (40.19) | 0.70 (0.55, 0.88) |
Infections AEs of interest | Â | Â | Â |
Nasopharyngitis | 11.3, 67 (7.98) | 10.4, 11 (5.26) | 1.09 (0.57, 2.06) |
Pneumonia | 3.1, 19 (2.26) | 7.4, 8 (3.83) | 0.42 (0.18, 0.96) |
Upper RTI | 16.1, 94 (11.2) | 11.6, 12 (5.74) | 1.39 (0.76, 2.53) |
Meningitis viral | 0.4, 2 (0.2) | 0, 0 (0) | ND** |