Frequency of non-Hema AEs by type
. | All patients . | First cohort . | Second cohort . | Third cohort . |
|---|---|---|---|---|
| Adverse events, no. (grade) | 2 (3/4) | 2 (3/4) | 2 (3/4) | 2 (3/4) |
| Constitutional (muscle cramps, myalgia, arthralgia, musculoskeletal pain, fatigue, asthenia, fever, headache, flu-like syndrome), no. (%) | 43 (36) | 45 (11) | 56 (33) | 33 (60) |
| Skin (rash and related events, pruritus), no. (%) | 22 (17) | 22 (15) | 5 (17) | 33 (19) |
| Neuro-psychiatric (polyneuropathy, depression), no. (%) | 13 (9) | 19 (7) | 5 — | 13 (16) |
| Gastrointestinal (nausea, vomiting, mucositis, abdominal pain, diarrhea), no. (%) | 17 (4) | 22 — | 28 — | 7 (9) |
| Edema (generalized, superficial, orbital, facial, weight gain), no. (%) | 15 (1) | 26 (4) | — — | 12 — |
| Liver (AST/ALT increase), no. (%) | 4 (4) | 4 — | 6 (5) | 4 (6) |
| Other no. (%) | 9 (5) | — — | 6 (5) | 16 (10) |
. | All patients . | First cohort . | Second cohort . | Third cohort . |
|---|---|---|---|---|
| Adverse events, no. (grade) | 2 (3/4) | 2 (3/4) | 2 (3/4) | 2 (3/4) |
| Constitutional (muscle cramps, myalgia, arthralgia, musculoskeletal pain, fatigue, asthenia, fever, headache, flu-like syndrome), no. (%) | 43 (36) | 45 (11) | 56 (33) | 33 (60) |
| Skin (rash and related events, pruritus), no. (%) | 22 (17) | 22 (15) | 5 (17) | 33 (19) |
| Neuro-psychiatric (polyneuropathy, depression), no. (%) | 13 (9) | 19 (7) | 5 — | 13 (16) |
| Gastrointestinal (nausea, vomiting, mucositis, abdominal pain, diarrhea), no. (%) | 17 (4) | 22 — | 28 — | 7 (9) |
| Edema (generalized, superficial, orbital, facial, weight gain), no. (%) | 15 (1) | 26 (4) | — — | 12 — |
| Liver (AST/ALT increase), no. (%) | 4 (4) | 4 — | 6 (5) | 4 (6) |
| Other no. (%) | 9 (5) | — — | 6 (5) | 16 (10) |
The frequency has been calculated as the percent of cases who suffered at least one adverse event (AE), grade 2 or grade 3/4. Notice that the frequencies that are shown in this table are greater than the frequencies shown in Table 3, because several patients suffered from the same AE, grade 2 and grade 3/4. For all patients, n = 76; first cohort, 27; second cohort, 18; and third cohort, 31.