Table 2.
IR (95% CI) per 100 person-years by TKIs | ||||||
---|---|---|---|---|---|---|
IM400 | IM800 | Nilotinib | Dasatinib | Ponatinib | Overall | |
Overall AEs | 9.6 (6.9-13.2) | 7.1 (5.8-8.7) | 9.7 (7.3-12.9) | 9.2 (6.9-12.1) | 42.2 (29.1-61.1) | 9.1 (8.1-10.3) |
CV-AEs | 9.0 (6.5-12.6) | 6.9 (5.6-8.5) | 9.1 (6.7-12.2) | 7.8 (5.8-10.6) | 40.7 (27.9-59.4) | 8.6 (7.6-9.8) |
CV-AEs without H.T. | 0.0 (0.0-0.2) | 0.1 (0.1-0.2) | 0.3 (0.2-0.5) | 0.4 (0.3-0.6) | 0.5 (0.2-1.3) | 0.2 (0.1-0.2) |
AT-AEs | 1.3 (0.5-3.1) | 0.7 (0.4-1.3) | 2.3 (1.3-4.1) | 2.9 (1.7-4.7) | 9.0 (4.1-20.1) | 1.7 (1.2-2.2) |
Overall H.T. | 8.8 (6.3-12.3) | 5.9 (4.7-7.3) | 5.4 (3.6-7.9) | 3.1 (1.9-5.0) | 34.7 (23.0-52.2) | 6.3 (5.5-7.4) |
New-onset H.T. | 5.7 (3.7-8.6) | 2.7 (1.9-3.8) | 2.3 (1.3-4.1) | 0.2 (0.0-1.4) | 13.6 (7.1-26.1) | 2.8 (2.3-3.5) |
Worsening H.T. | 3.1 (1.8-5.5) | 3.2 (2.3-4.3) | 3.1 (1.9-5.1) | 2.9 (1.7-4.7) | 21.1 (12.5-35.6) | 3.5 (2.9-4.3) |
CAD | 0.8 (0.3-2.4) | 0.4 (0.2-0.9) | 1.4 (0.7-3.0) | 1.7 (0.9-3.3) | 3.0 (0.8-12.1) | 0.9 (0.6-1.4) |
CVA* | 0.3 (0.0-1.8) | 0.2 (0.0-0.6) | 0.6 (0.2-1.9) | 0.6 (0.2-1.8) | 3.0 (0.8-12.1) | 0.4 (0.2-1.7) |
PAD† | 0 (0) | 0.2 (0.0-0.6) | 0 (0) | 0.4 (0.1-1.5) | 3.0 (0.8-12.1) | 0.1 (0.1-0.5) |
The IRs for overall AEs, new-onset CV-AEs, AT-AEs, hypertension (H.T.), new-onset H.T., CAD, CVA, and PAD.
CI, confidence interval.
Cerebrovascular (CVA) includes stroke/TIA.
P = not significant while P values were significant (<.05) for overall, CV-AEs, CV-AEs without H.T., AT-AEs, hypertension, new-onset AEs, and hypertension and CAD.