Table 3.
Distribution of Characteristics of Different Adverse Drug Events Suspected to Be Caused by Favipiravir Between Age <64 and >64 Years
| Parameters | Age <64 (N=133) | Age 64 and Above (N = 48) | Age Unknown (N = 13) |
|---|---|---|---|
| Seriousness | |||
| Serious (N = 63) | 35 (26.31) | 23 (47.91) | 5 (38.46) |
| Non-serious (N = 130) | 98 (73.68) | 25 (52.08) | 7 (53.84) |
| ADE organ system | |||
| Blood and lymphatic system disorders (N=5) | 3 (2.25) | 2 (4.1) | 0 |
| Cardiac disorders (N=14) | 9 (6.76) | 3 (6.25) | 2 (15.38) |
| Congenital, familial and genetic disorders (N = 1) | 1 (0.75) | 0 | 0 |
| Eye disorders (N=1) | 1 (0.75) | 0 | 0 |
| Gastrointestinal disorders (N=27) | 20 (15.03) | 6 (12.5) | 1 (7.69) |
| General disorders and administration site conditions (N = 3) | 2 (1.50) | 0 | 1 (7.69) |
| Hepatobiliary disorders (N = 5) | 4 (3.0) | 1 (2.08) | 0 |
| Immune system disorders (N = 1) | 1 (0.75) | 0 | 0 |
| Injury, poisoning and procedural complications (N = 65) | 44 (33.0) | 18 (37.5) | 3 (23.0) |
| Investigations (N = 29) | 21 (15.78) | 7 (14.58) | 1 (7.69) |
| Metabolism and nutrition disorders (N = 1) |
1 (0.75) | 0 | 0 |
| Musculoskeletal and connective tissue disorders (N = 3) | 1 (0.75) | 2 (4.16) | 0 |
| Nervous system disorders (N = 9) | 5 (3.75) | 3 (6.25) | 1 (7.69) |
| Renal and urinary disorders (N = 1) | 0 | 1 (2.08) | 0 |
| Respiratory, thoracic and mediastinal disorders (N = 4) | 1 (0.75) | 3 (6.25) | 0 |
| Skin and subcutaneous tissue disorders (N = 20) |
18 (13.53) | 1 (2.08) | 1 (2.08) |
| Vascular disorders (N = 5) | 1 (0.75) | 1 (2.08) | 3 (23.07) |
| Outcomes | |||
| Fatal (N =4) | 1 (0.75) | 0 | 3 (23.07) |
| Not recovered/Not resolved (N =15) | 8 (6.01) | 6 (12.50) | 1 (7.69) |
| Recovered/Resolved (N =27) | 18 (13.53) | 7 (14.58) | 2 (15.38) |
| Recovering/Resolving (N =11) | 10 (7.51) | 1 (2.08) | 0 |
| Unknown (N =21) | 16 (12.03) | 3 (6.25) | 2 (15.38) |
| Not Reported (N =116) | 80 (60.15) | 31 (64.58) | 5 (38.46) |