Table 3 Safety Analysis and overall Adverse Events
DCV + SOF (n=16) | ||||
Parameter | until EOT | until end of study | ||
No. of all AEs | 43 | 77 | ||
AEs suspected of being related to study drug | 5 | 5 | ||
No. of SAEs | 2 | 8 | ||
No. of SAEs which were in relation to study drug | 0 | 0 | ||
No. of patients with one or more AE | 12 | 14 | ||
No. of patients with one or more SAE | 2 | 4 | ||
No. of patients who needed hospitalization | 2 | 7 | ||
AE Drug related | SAE | |||
Gastrointestinal events, no., (% of al AEs) | 5 (11.63%) | 6 (7.79%) | ||
Nausea | 3 | 3 | yes | |
Diarrhea | 1 | 1 | ||
Gastro-enteritis | 2 | 2 | ||
Reflux/Gastritis | 1 | 2 | yes | |
Infection related events, no. (% of all AEs) | 17 (39.53%) | 31 (40.26%) | no | |
Urinary tract infection | 5 | 9 | 2 | |
Sepsis, 3-MRGN | 0 | 1 | 1 | |
C. difficile infection | 1 | 1 | 1 | |
Common cold | 4 | 10 | ||
Pneumonia/Bronchitis | 2 | 3 | 1 | |
Fever | 1 | 2 | ||
Conjunctivitis | 0 | 1 | ||
Epiglottitis | 1 | 1 | ||
Tonsillar angina | 1 | 1 | ||
No. of any Efficacy failure (%) of patients | 0 (0%) | 1 (6.25%) | ||
Viral breakthrough | 0 | 0 | ||
Viral relapse | 0 | 1 | 1 | |
Any Malignancies or any suspected Neoplasia , no.(%) of patients# | 1 (6.25%) | 2 (12.5%) | ||
PTLD* in liver | 1 | 1 | ||
Follow-up liver biopsy | 0 | 1 | 1 | |
Pituitary adenoma | 0 | 1 | 1 | |
Any Heart, Cardiovascular, no. (%) of all AEs | 2 (4.65%) | 2 (2.6%) | ||
Tachycardia | 1 | 1 | ||
Hypertension | 1 | 1 | ||
Any Neurological events, no. (%) of all AEs | 4 (9.3%) | 9 (11.69%) | ||
Concentration weakness | 1 | 2 | ||
Headache | 3 | 4 | ||
Dizziness | 0 | 1 | ||
Hyposphagma | 0 | 1 | ||
No. of any other AE. (%) of patients | 14 (32.56%) | 26 (33.77%) | ||
Asthma episode/ Dyspnoe | 1 | 5 | ||
Myalgia | 2 | 4 | ||
Lower back pain | 2 | 3 | ||
Fatigue | 1 | 2 | yes | |
Anemia/Iron deficiency | 3 | 3 | ||
Alopecia | 1 | 1 | ||
Leukocytosis | 1 | 1 | ||
Urinary incontinence | 1 | 1 | ||
Hyperkaliemia | 0 | 1 | ||
Hypercalcemia | 0 | 1 | ||
Edema | 2 | 2 | ||
Pancreatic cyst | 0 | 1 | ||
Rib fracture | 0 | 1 | ||