Safety and drug adherence
erythema, Treatment-emergent adverse, rash, pruritus, psychiatric, headache, dermatitis, injuries, eczema
RESPIRATORY DISORDERS, ERYTHEMA, SKIN AND SUBCUTANEOUS TISSUE DISORDER, GASTROINTESTINAL DISORDERS, DISORDERS, ACUTE HEPATITIS, CONJUNCTIVITIS, EVENTS, DERMATITIS, ECZEMA
A total of 23 over 42 individuals (55%) in the rapamycin group and 11 over 21 individuals (52%) in the placebo group had one or more AEs during the trial (Table Individuals with SAEs were 19% both in the placebo and in the rapamycin groups (Table Events occurring at a greater frequency in the rapamycin group were primarily skin and subcutaneous tissue disorders (erythema, pruritus, rash, conjunctivitis, dermatitis, eczema), then gastrointestinal disorders, injuries, respiratory disorders, headache and psychiatric disorders (Table Treatment-emergent adverse eventsOf note, there was a case of acute hepatitis probably related to the study drug, that occurred in a subject allocated to the rapamycin 2 mg/mA total of 11% of the participants dropped out during the study treatment, 5% in the placebo group and 14.3% in the rapamycin group. During follow up time, 24% of patients in each group abandoned the study. Events leading to discontinuation of the treatment are presented in Table 