Table 4.
Adverse Events | Entire | Sunitinib | Others | |||
---|---|---|---|---|---|---|
Placebo (n = 17) | RJ (n = 16) | Placebo (n = 11) | RJ (n = 10) | Placebo (n = 6) | RJ (n = 6) | |
Leukopenia | ||||||
Nothing | 11 (35.3) | 11 (25.0) | 5 (45.5) | 6 (60.0) | 6 (100.0) | 5 (83.3) |
Low | 5 (58.8) | 5 (75.0) | 5 (45.5) | 4 (40.0) | 0 (0.0) | 1 (16.7) |
High | 1 (5.9) | 0 (0.0) | 1 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
p value | 0.616 | 0.561 | 0.296 | |||
Anemia | ||||||
Nothing | 10 (58.8) | 14 (87.5) | 4 (36.4) | 8 (80.0) | 6 (100.0) | 6 (100.0) |
Mild | 6 (35.3) | 2 (12.5) | 4 (36.4) | 2 (20.0) | 0 (0.0) | 0 (0.0) |
Severe | 1 (5.9) | 0 (0.0) | 1 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
p value | 0.162 | 0.117 | > 0.999 | |||
Platelets | ||||||
Nothing | 5 (29.4) | 9 (56.3) | 2 (18.2) | 5 (50.0) | 3 (50.0) | 4 (66.7) |
Mild | 8 (47.1) | 4 (25.0) | 6 (54.5) | 3 (30.0) | 2 (33.3) | 1 (16.7) |
Severe | 4 (23.5) | 3 (18.8) | 3 (27.3) | 2 (20.0) | 1 (16.7) | 1 (16.7) |
p value | 0.274 | 0.295 | 0.788 | |||
Renal Dysfunction | ||||||
Nothing | 8 (47.1) | 10 (62.5) | 5 (45.5) | 6 (60.0) | 3 (50.0) | 4 (66.7) |
Mild | 9 (52.9) | 6 (37.5) | 6 (54.5) | 4 (40.0) | 3 (50.0) | 2 (33.3) |
Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
p value | 0.373 | 0.505 | 0.558 | |||
Liver Dysfunction | ||||||
Nothing | 12 (70.6) | 14 (87.5) | 7 (63.6) | 9 (90.0) | 5 (83.3) | 5 (83.3) |
Mild | 4 (23.5) | 1 (6.3) | 4 (36.4) | 1 (10.0) | 0 (0.0) | 0 (0.0) |
Severe | 1 (5.9) | 1 (6.3) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (16.7) |
p value | 0.382 | 0.621 | 0.999 | |||
Thyroid Abnormality | ||||||
Nothing | 9 (52.9) | 10 (62.5) | 7 (63.6) | 7 (70.0) | 2 (33.3) | 3 (50.0) |
Mild | 7 (41.2) | 6 (37.5) | 4 (36.4) | 3 (30.0) | 3 (50.0) | 3 (50.0) |
Severe | 1 (5.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (16.7) | 0 (0.0) |
P value | 0.577 | 0.757 | 0.549 |