Table 2.
Adverse Events Related to the Study Drug.
| Adverse Event | Any Grade | Grade 3 | Grade 4 |
|---|---|---|---|
| number (percent) | |||
| Total | 130 (98) | 79 (60) | 5 (4)* |
|
| |||
| Arthralgia | 78 (59) | 8 (6) | — |
|
| |||
| Rash | 69 (52) | 9 (7) | — |
|
| |||
| Photosensitivity reaction | 69 (52) | 4 (3) | — |
|
| |||
| Fatigue | 56 (42) | 2 (2) | — |
|
| |||
| Alopecia | 48 (36) | — | — |
|
| |||
| Pruritus | 38 (29) | 3 (2) | — |
|
| |||
| Skin papilloma | 38 (29) | — | — |
|
| |||
| Cutaneous squamous-cell carcinoma or keratoacanthoma† | 34 (26) | 34 (26) | — |
|
| |||
| Nausea | 30 (23) | 2 (2) | — |
|
| |||
| Elevated liver enzymes | 23 (17) | 8 (6)‡ | 4 (3)§ |
|
| |||
| Peripheral neuropathy | 13 (10) | 1 (1) | — |
|
| |||
| Palmar–plantar erythrodysesthesia | 13 (10) | 2 (2) | — |
|
| |||
| Facial palsy | 3 (2) | 1 (1) | — |
|
| |||
| Hyperuricemia | 3 (2) | — | 1 (1) |
|
| |||
| Retinal-vein occlusion | 1 (1) | 1 (1)§ | — |
|
| |||
| Delirium | 1 (1) | 1 (1)§ | — |
*
One patient had two grade 4 adverse events.
†
Cases of cutaneous squamous-cell carcinoma or keratoacanthoma were generally managed with simple excision and did not usually require dose modification.
‡
Grade 3 elevated liver-enzyme levels were managed by reducing the dose of the study drug; one affected patient was removed from the study.
§
Grade 3 or 4 adverse events led to discontinuation of therapy.