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. 2020 Jan 17;19:100249. doi: 10.1016/j.eclinm.2019.100249

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.