Table 3.
Incidence rates of adverse events without diarrhea of grade 1 or higher and grade 2 or higher (CTCAE v.4.0-JCOG)
| No. of patients (%) | Difference between groups | |||
|---|---|---|---|---|
| Cystine/theanine (n = 49) | Placebo (n = 45) | Point estimation [90% CI], p value | ||
| Hand-foot syndrome* | Grade ≥ 1 | 33 (67.4) | 35 (77.8) | − 10.40 [− 27.05, 6.88], 0.185 |
| Grade ≥ 2 | 20 (40.8) | 20 (44.4) | − 3.60 [− 20.46, 13.64], 0.442 | |
| Nausea | Grade ≥ 1 | 8 (16.3) | 6 (13.3) | 3.00 [− 13.98, 19.95], 0.756 |
| Grade ≥ 2 | 2 (4.1) | 2 (4.4) | − 0.40 [− 17.48, 16.57], 0.659 | |
| Vomiting | Grade ≥ 1 | 2 (4.1) | 2 (4.4) | − 0.40 [− 17.48, 16.57], 0.659 |
| Grade ≥ 2 | 1 (2.0) | 1 (2.2) | − 0.20 [− 17.28, 16.83], 0.731 | |
| Anorexia | Grade ≥ 1 | 11 (22.5) | 9 (20.0) | 2.40 [− 14.61, 19.46], 0.705 |
| Grade ≥ 2 | 1 (2.0) | 4 (8.9) | − 6.80 [− 23.78, 10.12], 0.155 | |
| Mucositis oral | Grade ≥ 1 | 16 (32.7) | 14 (31.1) | 1.50 [− 15.65, 18.28], 0.648 |
| Grade ≥ 2 | 3 (6.1) | 3 (6.7) | − 0.50 [− 17.65, 16.29], 0.620 | |
| Constipation | Grade ≥ 1 | 3 (6.1) | 3 (6.7) | − 0.50 [− 17.65, 16.29], 0.620 |
| Grade ≥ 2 | No data | No data | ||
| Malaise | Grade ≥ 1 | 12 (24.5) | 9 (20.0) | 4.50 [− 12.64, 21.43], 0.779 |
| Grade ≥ 2 | 3 (6.1) | 2 (4.4) | 1.70 [− 15.48, 18.52], 0.792 | |
| Abdominal pain | Grade ≥ 1 | 7 (14.3) | 4 (8.9) | 5.40 [− 11.74, 22.19], 0.872 |
| Grade ≥ 2 | 1 (2.0) | No data | 2.00 [− 15.09, 19.03], 1.000 | |
| Skin and subcutaneous tissue disorders | Grade ≥ 1 | 7 (14.3) | 5 (11.1) | 3.20 [− 13.89, 20.08], 0.778 |
| Grade ≥ 2 | 1 (2.0) | 2 (4.4) | − 2.40 [− 19.46, 14.61], 0.468 | |
| Skin hyperpigmentation | Grade ≥ 1 | 27 (55.1) | 20 (44.4) | 10.70 [− 6.66, 27.51], 0.892 |
| Grade ≥ 2 | 2 (4.1) | No data | 4.10 [− 13.10, 20.99], 1.000 | |
| Fever | Grade ≥ 1 | 1 (2.0) | 1 (2.2) | − 0.20 [− 17.28, 16.83], 0.731 |
| Grade ≥ 2 | No data | No data | ||
| Decreased white blood cell count | Grade ≥ 1 | 13 (26.5) | 11 (24.4) | 2.10 [− 15.09, 19.03], 0.680 |
| Grade ≥ 2 | 12 (24.5) | 8 (17.8) | 6.70 [− 10.40, 23.60], 0.852 | |
| Decreased neutrophil count | Grade ≥ 1 | 27 (55.1) | 21 (46.7) | 8.40 [− 8.89, 25.35], 0.847 |
| Grade ≥ 2 | 14 (28.6) | 12 (26.7) | 1.90 [− 15.30, 18.79], 0.668 | |
| Anemia | Grade ≥ 1 | 17 (34.7) | 17 (37.8) | − 3.10 [− 20.08, 13.98], 0.461 |
| Grade ≥ 2 | 1 (2.0) | 3 (6.7) | − 4.60 [− 21.63, 12.37], 0.277 | |
| Decreased platelet count | Grade ≥ 1 | 13 (26.5) | 14 (31.1) | − 4.60 [− 21.63, 12.37], 0.396 |
| Grade ≥ 2 | No data | No data | ||
| Increased AST | Grade ≥ 1 | 18 (36.7) | 6 (13.3) | 23.40 [6.21, 39.45], 0.998 |
| Grade ≥ 2 | No data | No data | ||
| Increased ALT | Grade ≥ 1 | 15 (30.6) | 5 (11.1) | 19.50 [2.41, 35.83], 0.996 |
| Grade ≥ 2 | No data | No data | ||
| Increased blood bilirubin | Grade ≥ 1 | 13 (26.5) | 7 (15.6) | 11.00 [− 6.16, 27.70], 0.941 |
| Grade ≥ 2 | 3 (6.1) | 1 (2.2) | 3.90 [− 13.30, 20.73], 0.931 | |
| Increased ALP | Grade ≥ 1 | 9 (18.4) | 5 (11.1) | 7.30 [− 9.79, 24.08], 0.900 |
| Grade ≥ 2 | No data | No data | ||
| Increased GGT | Grade ≥ 1 | 15 (30.6) | 7 (15.6) | 15.10 [− 2.16, 31.59], 0.976 |
| Grade ≥ 2 | 1 (2.0) | No data | 2.00 [− 15.09, 19.03], 1.000 | |
| Increased creatinine | Grade ≥ 1 | 28 (57.1) | 22 (48.9) | 8.30 [− 9.09, 25.12], 0.843 |
| Grade ≥ 2 | 2 (4.1) | 1 (2.2) | 1.90 [− 15.30, 18.79], 0.863 | |
CTCAE v.4.0-JCOG Common Terminology Criteria for Adverse Events version 4.0-Japanese Clinical Oncology Group version, AST aspartate aminotransferase, ALT alanine aminotransferase, ALP alkaline phosphatase, GGT γ-glutamyltransferase
*Described as palmar-plantar erythrodysesthesia syndrome according to CTCAE v.4.0-JCOG