Table 6.
Differences in clinical characteristics of severe and non-severe AEs
| Characteristics | Serious cases | Non-serious cases | Statistic | p-value |
|---|---|---|---|---|
| Sex, N (%) | ||||
| Female | 22 (61.11) | 11 (37.93) | 3.453a | 0.06 |
| Male | 14 (38.89) | 18 (62.07) | ||
| Age, years | ||||
| Median (IQR) | 66 (66, 71) | 68 (68, 69) | 0.17b | 0.86 |
| Infigratinib dose, mg | ||||
| Mean ± SD | 113.82 ± 16.13 | 125 ± 0.00 | − 4.28c | < 0.001 |
| Types of AEs, N (%) | ||||
| Alopecia | 2 (5.13) | 2 (6.90) | 11.76d | 0.93 |
| Arthralgia | 1 (2.56) | 0 (0.00) | ||
| Blood phosphorus increased | 2 (5.13) | 2 (6.90) | ||
| Constipation | 3 (7.69) | 1 (3.45) | ||
| Decreased appetite | 4 (10.26) | 1 (3.45) | ||
| Dehydration | 3 (7.69) | 1 (3.45) | ||
| Diarrhea | 3 (7.69) | 1 (3.45) | ||
| Dry eye | 2 (5.13) | 1 (3.45) | ||
| Dry mouth | 2 (5.13) | 1 (3.45) | ||
| Dry skin | 3 (7.69) | 1 (3.45) | ||
| Fatigue | 5 (12.82) | 3 (10.34) | ||
| Hyperphosphatemia | 0 (0.00) | 2 (6.90) | ||
| Malignant neoplasm progression | 1 (2.56) | 3 (10.34) | ||
| Nail disorder | 1 (2.56) | 2 (6.90) | ||
| Nausea | 1 (2.56) | 1 (3.45) | ||
| Onychomadesis | 1 (2.56) | 3 (10.34) | ||
| Skin exfoliation | 1 (2.56) | 1 (3.45) | ||
| Stomatitis | 2 (5.13) | 2 (6.90) | ||
| Vomiting | 2 (5.13) | 1 (3.45) |
AE adverse event, IQR interquartile range, SD standard deviation
aPearson’s chi-squared (χ2) test
bKruskal-Wallis test
cIndependent samples t test
dFisher’s exact test