Table 3.
The pooled results and evidence quality in safety outcomes
| Outcome | RCT | NRCT | Cohort study | |||
|---|---|---|---|---|---|---|
| Estimate (95% CI) | Evidence quality a | Estimate (95% CI) | Evidence quality a | Estimate (95% CI) | Evidence quality a | |
| Myelosuppression | RR 0.55 (0.32–0.96) * | Moderate | RR 0.38 (0.20–0.72) * | Low | RR 1.11 (0.59–2.10) | Very low |
| Grade 3/4 myelosuppression | RR 0.70 (0.29–1.66) | Low | RR 0.20 (0.01–3.92) | Very low | RR 1.25 (0.30–5.15) | Very low |
| Leukopenia | – | – | RR 0.44 (0.18–1.11) | Very low | RR 1.12 (0.79–1.58) | Very low |
| Grade 3/4 leukopenia | – | – | – | – | RR 0.80 (0.33–1.93) | Very low |
| Neutropenia | – | – | RR 0.55 (0.28–1.06) | Very low | RR 1.04 (0.89–1.22) | Very low |
| Grade 3/4 neutropenia | – | – | – | – | RR 0.96 (0.64–1.43) | Very low |
| Anemia | – | – | RR 0.43 (0.14–1.33) | Very low | RR 1.05 (0.92–1.20) | Very low |
| Grade 3/4 anemia | – | – | – | – | RR 0.95 (0.46–1.97) | Very low |
| Thrombocytopenia | – | – | – | – | RR 1.15 (0.74–1.79) | Very low |
| Grade 3/4 thrombocytopenia | – | – | – | – | RR 1.30 (0.49–3.47) | Very low |
| Hemorrhage | – | – | – | – | – | – |
| Grade 3/4 hemorrhage | – | – | – | – | – | – |
| Laryngeal hemorrhage | – | – | – | – | RR 0.27 (0.09–0.84) * | Very Low |
| Cardiovascular toxicity | RR 0.21 (0.06–0.78) * | Moderate | RR 0.15 (0.02–1.20) | Very low | – | – |
| Cardiotoxicity | – | – | RR 0.26 (0.06–1.13) | Very low | – | – |
| Gastrointestinal Reaction | – | – | RR 0.83 (0.30–2.29) | Very low | RR 1.25 (0.30–5.15) | Very low |
| Grade 3/4 gastrointestinal response | – | – | RR 0.67 (0.12–3.57) | Very low | – | – |
| Nausea & vomiting | RR 0.88 (0.51–1.51) | Low | RR 0.58 (0.25–1.36) | Very low | RR 0.97 (0.72–1.31) | Very low |
| Grade 3/4 nausea & vomiting | RR 1.00 (0.38–2.60) | Low | RR 1.00 (0.16–6.14) | Very low | RR 1.25 (0.35–4.42) | Very low |
| Nausea | – | – | – | RR 1.17 (0.32–4.28) | Very low | |
| Vomiting | – | – | – | RR 1.23 (0.63–2.40) | Very low | |
| Diarrhea | RR 1.43 (0.60–3.40) | Low | – | – | RR 0.60 (0.18–1.96) | Very low |
| Constipation | – | – | – | RR 0.90 (0.53–1.54) | Very low | |
| Alopecia | RR 0.95 (0.82–1.09) | Moderate | RR 0.65 (0.42–1.00) * | Very low | RR 0.78 (0.31–1.95) | Very low |
| Neurotoxicity | RR 0.80 (0.23–2.77) | Low | – | – | – | – |
| Peripheral neurotoxicity | – | – | – | RR 0.58 (0.14–2.33) | Very low | |
| Liver dysfunction | RR 0.71 (0.39–1.29) | Low | – | – | RR 0.63 (0.20–2.01) | Very low |
| Grade 3/4 liver dysfunction | RR 0.60 (0.15–2.35) | Low | – | – | – | |
| Transaminase elevation | – | – | – | RR 1.48 (0.84–2.62) | Very low | |
| Fatigue | RR 1.14 (0.87–1.50) | Moderate | – | – | RR 0.90 (0.64–1.27) | Very low |
| Grade 3/4fatigue | RR 1.17 (0.43–3.18) | Low | – | – | – | – |
| Muscle & joint soreness | RR 0.71 (0.30–1.71) | Low | – | – | – | – |
| Rash | – | – | – | – | RR 0.61 (0.10–3.73) | Very low |
| Papule and purulent herpes | – | – | – | – | RR 1.60 (0.49–5.25) | Very low |
| Fever | – | – | – | – | RR 0.95 (0.48–1.88) | Very low |
| Thromboembolism | – | – | – | – | RR 0.48 (0.07–3.19) | Very low |
| Hyponatremia | – | – | – | – | RR 1.28 (0.71–2.29) | Very low |
| Grade 3/4 hyponatremia | – | – | – | – | RR 0.48 (0.10–2.19) | Very low |
| Pain | – | – | – | – | RR 1.00 (0.37–2.67) | Very low |
a The evidence quality was evaluated by GRADE. Moderate: we are moderately confident in the effect estimate (the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different); Low: our confidence in the effect estimate is limited (the true effect may be substantially different from the estimate of the effect); Very low: we have very little confidence in the effect estimate (the true effect is likely to be substantially different from the estimate of effect)
* A statistically significant difference exists (P < 0.05)