Table 3.
Comparison of 2012 versus 2019 Safety Outcomes and Quality of Safety Reporting Findings.
| Safety Outcomes | 2012 SafeCell SR |
2018 SafeCell SR Update |
||
|---|---|---|---|---|
| # of RCTs* | Findings (RR, 95% CI) | # of RCTS* | Findings (RR, 95% CI) | |
| Infusional toxicity- non-fever | 4/8 | 2·01 (0·34–11·77) | 32/55 | 1·16 (0·70–1·91) |
| Infusional toxicity- fever | 4/8 | 9·28 (2·02–42·71) | 19/55 | 2·48 (1·27–4·86) |
| Infection | 4/8 | 1·09 (0·61–1·94) | 27/55 | 0·99 (0·81–1·21) |
| Malignancy or ectopic tissue formation | 4/8 | 2·21 (0·85–5·74) | 19/55 | 0·93 (0·60–1·45) |
| Mortality | 8/8 | 1·22 (0·71–2·10) | 40/55 | 0·78 (0·65–0·94) |
| Thrombotic or embolic events | 4/8⁎⁎ | 2·71 (0·86–8·48) | 24/55 | 1·14 (0·67–1·95) |
| Quality of Safety Reporting | # of RCTs* | Findings (%) | # of RCTs* | Findings (%) |
| A priori plan to monitor adverse events | 3/8 | 37·5% | 43/55 | 78·2% |
That reported the adverse event.
Original review did not report on this outcome, but event rate is inserted for comparison purposes.