Table 4.
Adverse Events Related to Ezatiostat in Combination with Lenalidomide for Both Dose Groups Combined
|
NCI-CTCAE v3.0 Maximum Toxicity Grade (N = 19) | ||||||
|---|---|---|---|---|---|---|
|
Adverse Event (Preferred Term) |
Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
Total |
|
| n (%) | n (%) | n (%) | n (%) | n (%) | ||
|
Hematologic (All Patients) | ||||||
| Thrombocytopenia |
1 (5) |
1 (5) |
4 (21) |
3 (16) |
9 (47) |
|
| Neutropenia |
0 |
2 (11) |
2 (11) |
2 (11) |
6 (32) |
|
| Anemia |
0 |
0 |
3 (16) |
1 (5) |
4 (21) |
|
| Febrile Neutropenia |
0 |
0 |
2 (11) |
0 |
2 (11) |
|
|
Non-Hematologic (≥ 5% of Patients) | ||||||
| Diarrhoea |
5 (26) |
3 (16) |
3 (16) |
0 |
11 (58) |
|
| Nausea |
7 (37) |
3 (16) |
1 (5) |
0 |
11 (58) |
|
| Vomiting |
6 (32) |
4 (21) |
1 (5) |
0 |
11 (58) |
|
| Fatigue |
1 (5) |
5 (26) |
0 |
0 |
6 (32) |
|
| Skin Odour Abnormal |
3 (16) |
1 (5) |
0 |
0 |
4 (21) |
|
| Abdominal Pain Upper |
2 (11) |
1 (5) |
0 |
0 |
3 (16) |
|
| Anorexia |
2 (11) |
1 (5) |
0 |
0 |
3 (16) |
|
| Rash |
0 |
1 (5) |
2 (11) |
0 |
3 (16) |
|
| Constipation |
2 (11) |
0 |
0 |
0 |
2 (11) |
|
| Flatulence |
1 (5) |
1 (5) |
0 |
0 |
2 (11) |
|
| Muscle Spasms |
1 (5) |
0 |
1 (5) |
0 |
2 (11) |
|
| Muscular Weakness |
0 |
1 (5) |
1 (5) |
0 |
2 (11) |
|
| Oedema Peripheral | 1 (5) | 1 (5) | 0 | 0 | 2 (11) | |
Abbreviations: NCI-CTCAE v3.0 National Cancer Institute − Common Toxicity Criteria for Adverse Events, Version 3.0.