Agitation 1 (0.3%) 0 Anxiety 20 (5.1%) 33 (8.4%) Completed suicide 0 1 (0.3%) Confusional state 2 (0.5%) 2 (0.5%) Depression 26 (6.6%) 35 (8.9%) Euphoric mood 1 (0.3%) 2 (0.5%) Hallucination 0 2 (0.5%) Hallucination, auditory 0 1 (0.3%) Nervousness 0 1 (0.3%) Paranoia 0 3 (0.8%) Suicidal ideation 3 (0.8%) 3 (0.8%) Rash events 68 (17.3%) 83 (21.2%) 0.17 Blister 2 (0.5%) 1 (0.3%) Dermatitis allergic 1 (0.3%) 1 (0.3%) Erythema 0 2 (0.5%) Folliculitis 21 (5.3%) 4 (1.0%) Photosensitivity reaction 1 (0.3%) 0 Pruritis 14 (3.6%) 11 (2.8%) Rash (preferred term) 24 (6.1%) 47 (12.0%) Rash erythematous 0 1 (0.3%) Rash macular 2 (0.5%) 3 (0.8%) Rash maculo-papular 0 6 (1.5%) Rash papular 2 (0.5%) 1 (0.3%) Rash vesicular 1 (0.3%) 1 (0.3%) Skin exfoliation 1 (0.3%) 1 (0.3%)
Agitation 1 (0.3%) 0 Anxiety Completed suicide Confusional state Depression Euphoric mood Hallucination Hallucination, auditory Nervousness Paranoia 20 (5.1%) 0 2 (0.5%) 26 (6.6%) 1 (0.3%) 0 0 0 0 33 (8.4%) 1 (0.3%) 2 (0.5%) 35 (8.9%) 2 (0.5%) 2 (0.5%) 1 (0.3%) 1 (0.3%) 3 (0.8%) Suicidal ideation 3 (0.8%) 3 (0.8%) Rash events 68 (17.3%) 83 (21.2%) 0.17 Blister Dermatitis allergic Erythema Folliculitis Photosensitivity reaction Pruritis 2 (0.5%) 1 (0.3%) 0 21 (5.3%) 1 (0.3%) 14 (3.6%) 1 (0.3%) 1 (0.3%) 2 (0.5%) 4 (1.0%) 0 11 (2.8%) Rash (preferred term) Rash erythematous Rash macular Rash maculo-papular Rash papular Rash vesicular Skin exfoliation 24 (6.1%) 0 2 (0.5%) 0 2 (0.5%) 1 (0.3%) 1 (0.3%) 47 (12.0%) 1 (0.3%) 3 (0.8%) 6 (1.5%) 1 (0.3%) 1 (0.3%) 1 (0.3%)
QAD_2014_01_04_COHEN_AIDS-D-13-00893_SDC1.docx