Overview of TEAEs
| TEAE . | FL (n = 147) . | MZL (n = 82) . | DLBCL/MCL (n = 74) . | CLL/SLL (n = 43) . | Other (n = 25) . | Total (N = 371) . |
|---|---|---|---|---|---|---|
| Any TEAE | 144 (98.0) | 82 (100.0) | 72 (97.3) | 43 (100.0) | 25 (100.0) | 366 (98.7) |
| Related to umbralisib | 129 (87.8) | 79 (96.3) | 50 (67.6) | 38 (88.4) | 18 (72.0) | 314 (84.6) |
| Grade 3 or higher TEAE | 71 (48.3) | 47 (57.3) | 38 (51.4) | 26 (60.5) | 7 (28.0) | 189 (50.9) |
| Related to umbralisib | 43 (29.3) | 37 (45.1) | 18 (24.3) | 21 (48.8) | 5 (20.0) | 124 (33.4) |
| TEAE outcome of death* | 0 | 0 | 1 (1.4) | 2 (4.7)† | 0 | 3 (0.8)† |
| Serious TEAE | 34 (23.1) | 27 (32.9) | 17 (23.0) | 13 (30.2) | 4 (16.0) | 95 (25.6) |
| Related to umbralisib | 12 (8.2) | 21 (25.6) | 5 (6.8) | 6 (14.0) | 0 | 44 (11.9) |
| Grade 3 or higher serious TEAE | 29 (19.7) | 24 (29.3) | 17 (23.0) | 10 (23.3) | 2 (8.0) | 82 (22.1) |
| Related to umbralisib | 12 (8.2) | 19 (23.2) | 5 (6.8) | 5 (11.6) | 0 | 41 (11.1) |
| TEAE leading to umbralisib withdrawal | 18 (12.2) | 18 (22.0) | 9 (12.2) | 7 (16.3) | 5 (20.0) | 57 (15.4) |
| Related to umbralisib | 16 (10.9) | 15 (18.3) | 6 (8.1) | 6 (14.0) | 3 (12.0) | 46 (12.4) |
| TEAE leading to dose reduction | 18 (12.2) | 9 (11.0) | 4 (5.4) | 4 (9.3) | 4 (16.0) | 39 (10.5) |
| Related to umbralisib | 16 (10.9) | 7 (8.5) | 3 (4.1) | 4 (9.3) | 4 (16.0) | 34 (9.2) |
| TEAE leading to umbralisib interruption | 67 (45.6) | 47 (57.3) | 25 (33.8) | 23 (53.5) | 6 (24.0) | 168 (45.3) |
| Related to umbralisib | 52 (35.4) | 42 (51.2) | 15 (20.3) | 17 (39.5) | 5 (20.0) | 131 (35.3) |
| TEAE . | FL (n = 147) . | MZL (n = 82) . | DLBCL/MCL (n = 74) . | CLL/SLL (n = 43) . | Other (n = 25) . | Total (N = 371) . |
|---|---|---|---|---|---|---|
| Any TEAE | 144 (98.0) | 82 (100.0) | 72 (97.3) | 43 (100.0) | 25 (100.0) | 366 (98.7) |
| Related to umbralisib | 129 (87.8) | 79 (96.3) | 50 (67.6) | 38 (88.4) | 18 (72.0) | 314 (84.6) |
| Grade 3 or higher TEAE | 71 (48.3) | 47 (57.3) | 38 (51.4) | 26 (60.5) | 7 (28.0) | 189 (50.9) |
| Related to umbralisib | 43 (29.3) | 37 (45.1) | 18 (24.3) | 21 (48.8) | 5 (20.0) | 124 (33.4) |
| TEAE outcome of death* | 0 | 0 | 1 (1.4) | 2 (4.7)† | 0 | 3 (0.8)† |
| Serious TEAE | 34 (23.1) | 27 (32.9) | 17 (23.0) | 13 (30.2) | 4 (16.0) | 95 (25.6) |
| Related to umbralisib | 12 (8.2) | 21 (25.6) | 5 (6.8) | 6 (14.0) | 0 | 44 (11.9) |
| Grade 3 or higher serious TEAE | 29 (19.7) | 24 (29.3) | 17 (23.0) | 10 (23.3) | 2 (8.0) | 82 (22.1) |
| Related to umbralisib | 12 (8.2) | 19 (23.2) | 5 (6.8) | 5 (11.6) | 0 | 41 (11.1) |
| TEAE leading to umbralisib withdrawal | 18 (12.2) | 18 (22.0) | 9 (12.2) | 7 (16.3) | 5 (20.0) | 57 (15.4) |
| Related to umbralisib | 16 (10.9) | 15 (18.3) | 6 (8.1) | 6 (14.0) | 3 (12.0) | 46 (12.4) |
| TEAE leading to dose reduction | 18 (12.2) | 9 (11.0) | 4 (5.4) | 4 (9.3) | 4 (16.0) | 39 (10.5) |
| Related to umbralisib | 16 (10.9) | 7 (8.5) | 3 (4.1) | 4 (9.3) | 4 (16.0) | 34 (9.2) |
| TEAE leading to umbralisib interruption | 67 (45.6) | 47 (57.3) | 25 (33.8) | 23 (53.5) | 6 (24.0) | 168 (45.3) |
| Related to umbralisib | 52 (35.4) | 42 (51.2) | 15 (20.3) | 17 (39.5) | 5 (20.0) | 131 (35.3) |
Data are expressed as n (%). MCL, mantle cell lymphoma.
No deaths were related to umbralisib.
One additional death (pneumonia Legionella, in Study 1202-101) was recorded in the end-of-treatment summary case report form. AE outcome was not recorded as fatal in the AE case report form and is not included in this table.