Table 3.
TEAEs during the OLE period.
| Patients, n (%) | Treatment received during the DBP | |||
|---|---|---|---|---|
| Placebo + evobrutinib 25 mg QD |
Evobrutinib 25 mg QD |
Evobrutinib 75 mg QD |
Evobrutinib 75 mg BID |
|
| Treatment received during the OLE Evobrutinib 75 mg QD➔BID | ||||
| n = 39 | n = 39 | n = 42 | n = 44 | |
| Any TEAE | 30 (76.9) | 27 (69.2) | 40 (95.2) | 34 (77.3) |
| Any Grade 3 TEAE a | 4 (10.3) | 7 (17.9) | 7 (16.7) | 6 (13.6) |
| Any Grade 4 TEAE a | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (4.5) |
| TEAEs related to trial agent | 9 (23.1) | 5 (12.8) | 11 (26.2) | 13 (29.5) |
| Any serious TEAE | 6 (15.4) | 9 (23.1) | 5 (11.9) | 4 (9.1) |
| TEAEs leading to withdrawal of treatment b | 4 (10.3) | 2 (5.1) | 0 (0.0) | 1 (2.3) |
Includes all safety data from the OLE using a data cut-off of 30 September 2021.
According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03.
Of these, four patients had events considered to be treatment related (placebo + evobrutinib 25 mg QD/75 mg QD–BID, n = 2; evobrutinib 25 mg QD/75 mg QD–BID, n = 1; evobrutinib 75 mg BID/75 mg QD–BID, n = 1).
Two fatal events occurred in patients receiving evobrutinib in the DBP, which were not deemed to be treatment related by the investigators (evobrutinib 25 mg QD (n = 1): COVID-19 pneumonia (unvaccinated); evobrutinib 75 mg BID (n = 1): E. coli sepsis with febrile state and acute tubulointerstitial nephritis).
BID: twice-daily; DBP: double-blind period; OLE: open-label extension; QD: once-daily; TEAEs: treatment-emergent adverse events.