Table 3.
Clinical Adverse Events
| Clinical Adverse Eventsa,b | Lower | |
|---|---|---|
| Grade 1–2c | Grade 3–4d | |
| Cardiovascular | ||
| Hypertension | 24 (44) | 6 (11) |
| Thrombosis | 1 (2) | 1 (2) |
| Visceral arterial ischemia | 0 | 1 (2) |
| Constitutional | ||
| Fatigue | 27 (50) | 7 (13) |
| Weight loss | 14 (26) | 2 (4) |
| Fever | 4 (7) | 0 |
| Chills | 4 (7) | 0 |
| Dermatology | ||
| Rash, acneiform | 19 (35) | 0 |
| Rash, desquamating | 12 (22) | 1 (2) |
| Pruritis | 8 (15) | 0 |
| Alopecia | 6 (11) | 0 |
| Dry skin | 6 (11) | 0 |
| Nail disorder | 4 (7) | 0 |
| Skin disorder | 4 (7) | 0 |
| Skin ulceration | 3 (6) | 0 |
| Gastrointestinal | ||
| Anorexia | 21 (39) | 1 (2) |
| Diarrhea | 22 (41) | 2 (4) |
| Mucositis, oral | 20 (37) | 2 (4) |
| Nausea | 18 (33) | 1 (2) |
| Vomiting | 10 (19) | 0 |
| Taste alteration | 10 (19) | 0 |
| Gastrointestinal disorder | 6 (11) | 0 |
| Constipation | 5 (9) | 1 (2) |
| Hemorrhoids | 3 (6) | 1 (2) |
| Dry mouth | 3 (6) | 0 |
| Colonic perforation | 0 | 1 (2) |
| Hemorrhage | ||
| Epistaxis | 18 (33) | 1 (2) |
| Petechaie | 7 (13) | 0 |
| Pulmonary hemorrhage | 6 (11) | 2 (4) |
| Lower GI hemorrhage | 3 (6) | 3 (6) |
| Upper GI hemorrhage | 4 (8) | 1 (2) |
| Lymphatics | ||
| Edema of extremities | 9 (17) | 2 (4) |
| Localized edema | 4 (7) | 0 |
| Musculoskeletal | ||
| Muscle weakness | 3 (6) | 0 |
| Neurology | ||
| Insomnia | 6 (11) | 0 |
| Neurologic disorder NOS | 3 (6) | 0 |
| Peripheral sensory neuropathy | 3 (6) | 0 |
| Pain | ||
| Headache | 9 (17) | 3 (6) |
| Oral/pharyngolaryngeal pain | 7 (13) | 0 |
| Abdominal pain | 5 (9) | 2 (4) |
| Anal/rectal pain | 3 (6) | 1 (2) |
| Buttock pain | 1 (2) | 1 (2) |
| Pulmonary | ||
| Dyspnea | 6 (11) | 0 |
| Cough | 3 (6) | 0 |
| Nasal congestion | 3 (6) | 0 |
| Respiratory disorder | 3 (6) | 0 |
| Change in voice | 3 (6) | 0 |
a
National Cancer Institute Common Terminology Criteria for Adverse Events, criteria 3.0.
b
Three Grade 5 adverse events that occurred on trial (n=3) are described in the text.
c
Grade 1–2 adverse events that were possibly, probably, or definitely related to study treatment and occurred greater than or equal to 5% of the time. Not included in the table is one patient (1.8%) who experienced a Grade 2 intracranial hemorrhage without neurologic deficits, concurrent with a hypertensive emergency (Grade 4 HTN and Grade 3 headache).
d
Grade 3–4 adverse events that were possibly, probably, or definitely related to study treatment, regardless of frequency.