Table 4.
Parameters |
Age < 64 (N = 485) |
Age 64 & Above (N = 417) |
Age Unknown (N = 97) |
|
---|---|---|---|---|
Seriousness | ||||
Serious (N = 828) | 384 (79.2) | 373 (89.4) | 71 (73.2) | |
Non serious (N = 176) | 106 (21.8) | 44 (10.6) | 26 (26.8) | |
ADR organ system | ||||
Blood and lymphatic system disorders (N = 20) | 8 (1.6) | 7 (1.7) | 5 (5.2) | |
Cardiac disorders (N = 51) | 22 (4.5) | 27 (6.5) | 2 (2.1) | |
Ear and labyrinth disorders (N = 1) | 1 (0.2) | 0 | 0 | |
Eye disorders (N = 6) | 2 (0.4) | 0 | 4 (4.1) | |
Gastrointestinal disorders (N = 42) | 22 (4.5) | 16 (3.8) | 4 (4.1) | |
General disorders and administration site conditions (N = 84) | 39 (8.0) | 40 (9.6) | 5 (5.2) | |
Hepatobiliary disorders (N = 23) | 10 (2.1) | 8 (1.9) | 5 (5.2) | |
Immune system disorders (N = 1) | 1 (0.2) | 0 | 0 | |
Infections and infestations (N = 36) | 16 (3.3) | 16 (3.8) | 4 (4.1) | |
Injury, poisoning and procedural complications (N = 73) | 36 (7.4) | 28 (6.7) | 9 (9.3) | |
Investigations (N = 283) | 165 (34.0) | 88 (21.1) | 30 (30.9) | |
Metabolism and nutrition disorders (N = 22) |
11 (2.3) | 8 (1.9) | 3 (3.1) | |
Musculoskeletal and connective tissue disorders (N = 5) | 0 | 3 (0.7) | 2 (2.1) | |
Nervous system disorders (N = 34) | 11 (2.3) | 21 (5.0) | 2 (2.1) | |
Psychiatric disorders (N = 10) | 3 (0.6) | 7 (1.7) | 0 | |
Renal and urinary disorders (N = 102) | 35 (7.2) | 58 (13.9) | 9 (9.3) | |
Reproductive system and breast disorders (N = 1) | 1 (0.2) | 0 | 0 | |
Respiratory, thoracic and mediastinal disorders (N = 89) | 35 (7.2) | 49 (11.8) | 5 (5.2) | |
Skin and subcutaneous tissue disorders (N = 36) |
24 (4.9) | 7 (1.7) | 5 (5.2) | |
Social circumstances (N = 1) | 0 | 1 (0.2) | 0 | |
Surgical and medical procedures (N = 41) | 23 (4.7) | 17 (4.1) | 1 (1.0) | |
Vascular disorders (N = 43) | 25 (5.2) | 16 (3.8) | 2 (2.1) | |
Outcome | Fatal (N = 58) | 9 (1.9) | 42 (10.1) | 7 (7.2) |
Not recovered/Not resolved (N = 122) | 67 (13.8) | 19 (4.6) | 36 (37.1) | |
Recovered/Resolved (N = 101) | 62 (12.8) | 15 (3.6) | 24 (24.7) | |
Recovered/Resolved with sequelae (N = 1) | 0 | 0 | 1 (1.0) | |
Recovering/Resolving (N = 30) | 11 (2.3) | 10 (2.4) | 9 (9.3) | |
Unknown (N = 93) | 50 (10.3) | 25 (6.0) | 18 (18.6) | |
Not Reported (N = 599) | 291 (6) | 306 (73.4) | 2 (2.1) |
NB: Values in parenthesis are percentages. The denominator for the percentages are people in each age category.