Table 4.
GRADE evidence profile of clinical efficacy and safety.
| Out comes (trials) | Quality assessment |
No of patients |
Clinical efficacy and safety |
Quality | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Aidi plus GBC | GBC | Relative ratio (95% CI) | Absolute effects | ||
| ORR (50) | Seriousa | No serious | No serious | No serious | None | 1041/1894 (55.0%) | 735/1848 (39.8%) | 1.38 (1.29–1.48) | 151 more per 1000 (from 115 more to 191 more) | ⊕⊕⊕ moderate |
| DCR (49) | Seriousa | No serious | No serious | No serious | None | 1604/1876 (85.5%) | 1355/1826 (74.2%) | 1.15 (1.12–1.19) | 111 more per 1000 (from 89 more to 141 more) | ⊕⊕⊕ moderate |
| QOL (24) | Seriousa | No serious | No serious | No serious | None | 565/960 (58.9%) | 311/909 (34.2%) | 1.71 (1.54–1.89) | 243 more per 1000 (from 185 more to 304 more) | ⊕⊕⊕ moderate |
| Gastrointestinal toxicity (33) | Seriousa | No seriousb | No serious | No serious | Nonec | 458/1352 (33.9%) | 703/1332 (52.8%) | 0.64 (0.59–0.70) | 190 fewer per 1000 (from 158 fewer to 216 fewer) | ⊕⊕⊕ moderate |
| Thrombocytopenia (17) | Seriousa | No seriousb | No serious | No serious | None | 134/653 (20.5%) | 198/647 (30.6%) | 0.64 (0.54–0.77) | 110 fewer per 1000 (from 70 fewer to 141 fewer) | ⊕⊕⊕ moderate |
| Neutropenia (37) | Seriousa | No seriousb | No serious | No serious | Nonec | 457/1335 (34.2%) | 702/1313 (53.5%) | 0.63 (0.58–0.69) | 198 fewer per 1000 (from 166 fewer to 225 fewer) | ⊕⊕⊕ moderate |
| Liver injury (20) | Seriousa | No serious | No serious | No serious | Nonec | 123/869 (14.3%) | 215/861 (25.0%) | 0.57 (0.47–0.69) | 107 fewer per 1000 (from 77 fewer to 132 fewer) | ⊕⊕⊕ moderate |
| Renal injury (7) | Seriousa | No serious | No serious | Seriousd | None | 27/325 (8.3%) | 56/117 (13.3%) | 0.48 (0.31–0.74) | 92 fewer per 1000 (from 46 fewer to 122 fewer) | ⊕⊕ low |
| Anaemia (7) | Seriousa | No serious | No serious | Seriousd | None | 61/370 (16.5%) | 105/369 (28.5%) | 0.58 (0.44–0.76) | 120 fewer per 1000 (from 68 fewer to 159 fewer) | ⊕⊕ low |
Note: Aidi: Aidi injection; GBC: gemcitabine-based chemotherapy; RR, relative ratio; CI: confidence interval; ORR: objective response rate; DCR: disease control rate; QOL: quality of life.
aMost domain trials mentioned applying a randomisation methodology, but few of included study specified the method and none of the trials specified the methods of allocation concealment and the blinding procedures. Therefore, evidence was rated down by only one level.
bConsiderable heterogeneity and the results had good robustness. Not rated down
cNot rated down. The ADRs were over-estimated.
dThe total sample size did not reach the optimal information size, and the sample size for each indicator was less than 300 cases, and the evidence was rated down by one level.