Table 4.
Incidence rate of grade 3/4 adverse events of special interest in each study and meta-analysis of risk difference.
| Bi-weekly schedule | Weekly schedule | Pooled Risk Difference (%)a | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse events | CECOGN = 77 | NORDICN = 152 | CELINEN = 60 | OPTIMIXN = 99 | APEC (FOLFIRI)N = 101 |
APECN (FOFOLX)N = 188 |
CECOGN = 75 | NORDICN = 109 | CRYSTALb (CELINE)N = 303 |
CRYSTALb (OPTIMIX)N = 303 |
CRYSTALb (APEC)N = 303 |
CRYSTALb (APEC)N = 303 |
Bi-weekly -Weekly Mean (95% CI) |
| Paronychia | NR | NR | 18.3 | NR | 9.9 | 7.4 | NR | NR | 4.6 | 4.3 | 4.7 | 4 | 6.2 [2.6, 9.7] |
| Neutropenia | 36 | 40 | NR | 32 | 35.6 | 38.8 | 31 | 49 | 29.1 | 29.4 | 29.5 | 29.4 | 4.0 [−0.9, 8.9] |
| Diarrhea | 10 | 9 | 0 | 13.1 | 11.9 | 8.5 | 8 | 16 | 12.5 | 14.6 | 14.7 | 14.2 | −4.6 [−7.6, −1.7] |
| Rasha | 17 | 9 | 8.3 | NR | 4 | 15.4 | 15 | 29 | 7.4 | 10.7 | 9.7 | 9.5 | −3.1 [−11.1, 4.9] |
| Dermatitis acneiform | 8 | NR | NR | NR | 5 | 1.6 | 4 | NR | NR | NR | 4.6 | 4.8 | −1.0 [−3.5, 1.6] |
| Palmar-plantar Erythrodysesthesia Syndrome | NR | NR | NR | NR | 2 | 4.3 | NR | NR | NR | NR | 4 | 4.2 | −0.8 [−3.4, 1.8] |
| Cardiopulmonary arrest | NR | NR | NR | NR | 3 | 1.6 | NR | NR | NR | NR | 7.2 | 5.5 | −4.1 [−6.7, −1.5] |
| Hypomagnesemia | 1 | NR | NR | 1 | NR | NR | 1 | NR | NR | NR | NR | NR | 0.7 [−1.4, 2.7] |
| Nail toxicity | 6 | 2 | NR | 6.1 | NR | NR | 8 | 6 | NR | 4.3 | 4.7 | 4 | −1.2 [−4.6, 2.2] |
| Sepsis | NR | NR | NR | NR | 4 | 2.1 | NR | NR | NR | NR | 1.4 | 0.8 | 1.9 [−0.2, 4.0] |
| Acne-like rash | 25 | NR | NR | 15.2 | 10.9 | 18.6 | 19 | NR | NR | 18.6 | 17.4 | 16.7 | −1.0 [−5.2, 3.1] |
| Infusion related reaction | 3 | NR | 1.7 | 0 | 0 | 4.8 | 3 | NR | 0.8 | 0.8 | 1.4 | 1.5 | 0.7 [−0.7, 2.2] |
The estimated pooled risk difference is a weighted average effect size by sample size of each study through the selected studies.
The adverse events rates for CRYSTAL study presented on this table were adjusted to match with the baseline disease characteristics of study CELINE, OPTIMAX, APEC-FOLFIRI arm and APEC FOLFOX arm respectively.
Abbreviations: N, number of patients; NR, not reported.