Table 5.
SYSTEM ORGAN CLASS | ADVERSE EVENT | FORMULATION | |||||
---|---|---|---|---|---|---|---|
NON EMULSIVE-SC | EMULSIVE-IM | TOTAL | |||||
# | % | # | % | # | % | ||
General disorders and administration site conditions | Site reaction | 176 | 42.3 | 27 | 25 | 203 | 38.7 |
Asthenia | 27 | 6.5 | 5 | 4.6 | 32 | 6.1 | |
Fever | 26 | 6.2 | 1 | 0.9 | 27 | 5.2 | |
Chills | 15 | 3.6 | 5 | 4.6 | 20 | 3.8 | |
| |||||||
Nervous system disorders | Headache | 25 | 6 | 4 | 3.7 | 29 | 5.5 |
Metabolism and nutrition disorders | Anorexia | 4 | 0.9 | 3 | 2.7 | 7 | 1.3 |
Gastrointestinal disorders | Diarrhea | 2 | 0.4 | 1 | 0.9 | 3 | 0.5 |
Musculoskeletal and connective tissue disorders | Muscle pain | 3 | 0.7 | 8 | 7.4 | 11 | 2.1 |
Arthralgia | 5 | 1.2 | 1 | 0.9 | 6 | 1.1 | |
Other | Other | 133 | 31.9 | 53 | 49.1 | 186 | 35.4 |