Table 3 Characterization of the adverse events registered
Characteristic | Classification | Group A | Group B | Total |
|---|---|---|---|---|
Number of events | 17 (38.6%) | 27 (61.4%) | 44 (100%) | |
Severity | Non-severe | 17 (100%) | 27(100%) | 44 (100%) |
Intensity | Grade 1 | 15 (88.2%) | 27 (100%) | 42 (95.5%) |
Grade 2 | 2 (11.8%) | -- | 2 (4.5%) | |
Causality | Certain | -- | 11 (40.7%) | 11 (25.0%) |
Probable | 8 (47.1%) | 2 (7.4%) | 10 (22.7%) | |
Possible | 7 (41.1%) | 5 (18.5%) | 12 (27.3%) | |
Unlikely | -- | 4 (14.8%) | 4 (9.1%) | |
Not related | 2 (11.8%) | 4 (14.8%) | 6 (13.6%) | |
Unclassifiable | -- | 1 (3.7%) | 1 (2.3%) | |
Conduct | Pharmacotherapy | 3 (17.7%) | 1 (3.7%) | 4 (9.1%) |
Other intervention | -- | 1 (3.7%) | 1 (2.3%) | |
Observational | 14 (82.3%) | 25 (92.6%) | 39 (88.6%) | |
Result | Resolved | 14 (82.3%) | 22 (81.5%) | 36 (81.8%) |
Improved | 1 (5.9%) | -- | 1 (2.3%) | |
Persisted | 2 (11.8%) | 5 (18.5%) | 7 (15.9%) | |