Frequency of non-Hema AEs, by type, in this study and in a prior study of IM alone, 400 mg/day
. | No. adverse events per patient . | . | |
|---|---|---|---|
| Adverse events, grades 2, 3, and 4 . | This study, IM + PegIFN . | Prior study,44 IM alone . | |
| Constitutional (muscle cramps, myalgia, arthralgia, musculoskeletal pain, fatigue, astenia, fever, headache, flu-like syndrome) | 1.04 | 0.28 | |
| Skin (rash and related events, pruritus) | 0.74 | 0.13 | |
| Neuro-psychiatric (polyneuropathy, depression) | 0.39 | 0.08 | |
| Gastrointestinal (nausea, vomiting, mucositis, abdominal pain, diarrhea) | 0.26 | 0.12 | |
| Edema (generalized, superficial, orbital, facial, weight gain) | 0.21 | 0.08 | |
| Liver | 0.10 | 0.10 | |
. | No. adverse events per patient . | . | |
|---|---|---|---|
| Adverse events, grades 2, 3, and 4 . | This study, IM + PegIFN . | Prior study,44 IM alone . | |
| Constitutional (muscle cramps, myalgia, arthralgia, musculoskeletal pain, fatigue, astenia, fever, headache, flu-like syndrome) | 1.04 | 0.28 | |
| Skin (rash and related events, pruritus) | 0.74 | 0.13 | |
| Neuro-psychiatric (polyneuropathy, depression) | 0.39 | 0.08 | |
| Gastrointestinal (nausea, vomiting, mucositis, abdominal pain, diarrhea) | 0.26 | 0.12 | |
| Edema (generalized, superficial, orbital, facial, weight gain) | 0.21 | 0.08 | |
| Liver | 0.10 | 0.10 | |
The frequency was calculated as the number of adverse events (AEs) per patient, over a 1-year period. For this study, n = 76; for the study using IM alone, n = 191.