Ibrutinib studies with reported sudden deaths/cardiac arrests
| Studies* . | No. of Patients . | Median time on therapy (months) . | Age (y) . | No. of sudden deaths/cardiac arrests in ibrutinib arm . | Incidence per 100 000 patient-years (95% CI) . | Reference . | |
|---|---|---|---|---|---|---|---|
| Median . | Range . | ||||||
| OSU experience: NCT01105247, NCT01217749, NCT01589302, NCT01578707 (RESONATE) | 308 | 20 | 65 | 26-91 | 1 | 194.8 (4.9-1085.4) | 22 |
| NCT01722487 (RESONATE-2) | 135 | 17.4 | 73 | 65-89 | 2 | 1021.7 (123.7-3690.8) | 5 |
| MDACC experience: NCT01105247, NCT01520519, NCT01752426, NCT01578707 (RESONATE) | 127 | 13 | 61 | 36-83 | 2 | 1453.7 (176.1-5252.1) | 23 |
| NCT01500733 (Phase 2 NHLBI) | 51 | 24† | 62 | 33-82 | 1 | 980.4 (24.8-5462.4) | 24 |
| Swedish Compassionate Use | 95 | 10.2† | 69 | 42-86 | 1 | 1238.4 (31.4-6899.9) | 25 |
| NCT01611090 (HELIOS) | 287 | 14.7 | 64 | 31-86 | 3 | 853.3 (176.0-2493.7) | 12 |
| Studies* . | No. of Patients . | Median time on therapy (months) . | Age (y) . | No. of sudden deaths/cardiac arrests in ibrutinib arm . | Incidence per 100 000 patient-years (95% CI) . | Reference . | |
|---|---|---|---|---|---|---|---|
| Median . | Range . | ||||||
| OSU experience: NCT01105247, NCT01217749, NCT01589302, NCT01578707 (RESONATE) | 308 | 20 | 65 | 26-91 | 1 | 194.8 (4.9-1085.4) | 22 |
| NCT01722487 (RESONATE-2) | 135 | 17.4 | 73 | 65-89 | 2 | 1021.7 (123.7-3690.8) | 5 |
| MDACC experience: NCT01105247, NCT01520519, NCT01752426, NCT01578707 (RESONATE) | 127 | 13 | 61 | 36-83 | 2 | 1453.7 (176.1-5252.1) | 23 |
| NCT01500733 (Phase 2 NHLBI) | 51 | 24† | 62 | 33-82 | 1 | 980.4 (24.8-5462.4) | 24 |
| Swedish Compassionate Use | 95 | 10.2† | 69 | 42-86 | 1 | 1238.4 (31.4-6899.9) | 25 |
| NCT01611090 (HELIOS) | 287 | 14.7 | 64 | 31-86 | 3 | 853.3 (176.0-2493.7) | 12 |
CI, confidence interval; MDACC, MD Anderson Cancer Center; NHLBI, National Heart, Lung, and Blood Institute; OSU, The Ohio State University.
Some of these long term follow-up studies report on patients from the same trials, but they report only on nonoverlapping sets of patients treated at the home institution.
Median follow-up time. Median time on therapy was not provided.