Table 1

Classification used to synthesise evidence from systematic reviews of targeted cancer therapies and cardiovascular toxicity

Classification for each cardiovascular eventConditions
Sufficient systematic review evidence of toxicityIf the following were all met:
(i) a statistically significant meta-estimate of effect (p<0.05);
(ii) the review was either high quality (AMSTAR score ≥8) or moderate quality (AMSTAR score 4–7), provided that the AMSTAR elements 7 and 8 were met*; and
(iii) the number of patients exposed to the agent was ≥1000.
Probable systematic review evidence of toxicityIf the following are all met:
(i) a statistically significant meta-estimate of effect (p<0.05);
(ii) the review was either high quality (AMSTAR score ≥8) or moderate quality (AMSTAR score 4–7), provided that the AMSTAR elements 7 and 8 were met*; and
(iii) the number of patients exposed to the agent was <1000.
Probable systematic review evidence of toxicityIf the following are all met:
(i) a statistically significant meta-estimate of effect (p<0.05);
(ii) the review was moderate quality (AMSTAR score 4–7), without satisfying AMSTAR elements 7 or 8*, or of low quality (AMSTAR score ≤3); and
(iii) the number of patients exposed to the agent was ≥1000.
Possible systematic review evidence of toxicityIf the following are all met:
(i) a statistically significant meta-estimate of effect (p<0.05);
(ii) review was either moderate quality (AMSTAR score 4–7), without satisfying AMSTAR elements 7 or 8*, or low quality (AMSTAR score ≤3); and
(iii) the number of patients exposed to the agent was <1000.
Sufficient systematic review evidence of no toxicityIf the following are all met:
(i) a statistically non-significant meta-estimate of effect (p>0.05);
(ii) the review was either high quality (AMSTAR score ≥8) or moderate quality (AMSTAR score 4–7), provided that the AMSTAR elements 7 and 8 were met*; and
(iii) the number of patients exposed to the agent was ≥1000.
Indeterminate systematic review evidence of no toxicityIf the following are all met:
(i) a statistically non-significant meta-estimate of effect (p>0.05);
(ii) the review was either high quality (AMSTAR score ≥8) or moderate quality (AMSTAR score 4–7), provided that the AMSTAR elements 7 & 8 were met*; and
(iii) the number of patients exposed to the agent was <1000.
Indeterminate systematic review evidence of no toxicityIf the following are all met:
(i) a statistically non-significant meta-estimate of effect (p>0.05);
(ii) the review was moderate quality (AMSTAR score 4–7), without satisfying both AMSTAR elements 7 and 8*, or low quality (AMSTAR score≤3); and
(iii) the number of patients exposed to the agent was of any size.
Indeterminate systematic review evidence of toxicityIf the only study examining the cardiovascular outcome did not report the number of patients exposed to the agent, regardless of effect or study quality.
  • *AMSTAR elements 7 and 8: quality of included studies was assessed, documented and used appropriately in formulating inclusions.

  • AMSTAR, Assessment of Multiple Systematic Reviews.