Table 2. Summary of findings table–GRADE Approach.
| Risk of hypertension and atrial fibrillation associated with Ibrutinib | ||||||
|---|---|---|---|---|---|---|
| Intervention: Ibrutinib; Comparison: Control | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) |
№ of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with Control | Risk with Ibrutinib | |||||
| Hypertension | 4 per 100 | 12 per 100 (7 to 22) | RR 2.82 (1.52 to 5.23) | 2580 (8 RCTs) | ⨁⨁⨁○ MODERATE | All studies had high-risk of bias due to selective reporting and only one trial had adequate blinding. Ibrutinib probably results in a large increase in hypertension risk. |
| Atrial fibrillation | 1 per 100 | 5 per 100 (2 to 8) | RR 4.69 (2.17 to 7.64) | 2580 (8 RCTs) | ⨁⨁⨁⨁ HIGH | All studies had high-risk of bias due to selective reporting and only one trial had adequate blinding. The very large effect documented consistent (5 RCTs with RR>5.0) upgraded the quality of evidence, despite the risk of bias Ibrutinib is likely to results in a very large increase in atrial fibrillation risk. |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: 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 certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.