Table 4.
All adverse reactions grouped by organ system
| Adverse events | CTCAE toxicity grade | |||
|---|---|---|---|---|
| Grade 1, a n (%) | Grade 2, a n (%) | Grade 3, a n (%) | Total/any grade, b n (%) | |
| Constitutional | ||||
| Fatigue | 19 (45.2) | 6 (14.3) | 5 (11.9) | 26 (61.9) |
| Fever | 1 (2.4) | 1 (2.4) | 1 (2.4) | |
| Flu like symptoms | 2 (4.8) | 2 (4.8) | 4 (9.5) | |
| Malaise | 2 (4.8) | 2 (4.8) | ||
| Pain | 2 (4.8) | 2(4.8) | 3(7.1) | 5 (11.9) |
| Dehydration | 1(2.4) | 3 (7.1) | 2(4.8) | 4(9.5) |
| Weight loss | 7 (16.7 | 2 (4.8) | 9 (21.4) | |
| Hematological | ||||
| Anemia | 2 (4.8) | 2 (4.8) | ||
| Thrombocytopenia | 1 (2.4) | 1 (2.4) | ||
| Gastrointestinal | ||||
| Nausea | 10 (23.8) | 7 (16.7) | 1 (2.4) | 17 (40.5) |
| Vomiting | 6 (14.3) | 5(11.9) | 1(2.4) | 11 (26.2) |
| Diarrhea | 12 (28.6) | 4 (9.5) | 1 (2.4) | 16 (38.1) |
| Dyspepsia | 1 (2.4) | 1 (2.4) | 2 (4.8) | |
| Gastritis | 2 (4.8) | 2 (4.8) | ||
| Enterocolitis | 1 (2.4) | 1 (2.4) | ||
| Flatulence/bloating | 2 (4.8) | 2 (4.8) | ||
| Anorexia | 13 (31) | 5 (11.9) | 17 (40.5) | |
| Ascites | 1 (2.4) | 1 (2.4) | ||
| Hepatobiliary side effect NOS | 1 (2.4) | 1 (2.4) | ||
| Gastrointestinal side effect NOS | 1 (2.4) | 1 (2.4) | 2 (4.8) | |
| Cardiovascular: Hypertension | 4 (9.5) | 6 (14.3) | 9(21.4) | |
| Respiratory: Hoarseness | 1 (2.4) | 1 (2.4) | 2 (4.8) | |
| Skin and mucosa | ||||
| Palmar‐plantar erythrodysesthesia syndrome | 33 (78.6) | 28 (66.7) | 16 (38.1) | 36 (85.7) |
| Photosensitivity | 3 (7.1) | 3 (7.1) | ||
| Pruritis | 1 (2.4) | 1 (2.4) | ||
| Maculopapular rash | 2 (4.8) | 1 (2.4) | 3 (7.1) | |
| Skin and subcutaneous tissue side effect NOS | 1 (2.4) | 1 (2.4) | 2 (4.8) | |
| Mucosal bleeding (epistaxis) | 1 (2.4) | 1 (2.4) | ||
| Oral mucositis | 4 (9.5) | 4 (9.5) | 2 (4.8) | 9 (21.4) |
| Musculoskeletal | ||||
| Arthralgia | 1 (2.4) | 1 (2.4) | ||
| Musculoskeletal side effect NOS | 2 (4.8) | 2(4.8) | 2 (4.8) | |
| Neurological | ||||
| Dysgeusia | 1 (2.4) | 1 (2.4) | ||
| Peripheral sensory neuropathy | 1 (2.4) | 1 (2.4) | 1 (2.4) | 3 (7.1) |
| Vertigo | 1 (2.4) | |||
| Infectious disease | ||||
| Pelvic infection | 1 (2.4) | 1 (2.4) | ||
| Splenic infection | 1 (2.4) | 1 (2.4) | ||
a
In each column, n represents a unique patient with the listed adverse event.
b
In this column, n represents the total number of patients with the listed adverse event.
Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; NOS, not otherwise specified.