Table 3.

Overall summary of TEAEs,in the safety population in Part 2

Ibrutinib plus RICE/RVICI (n = 35)RICE/RVICI (n = 15)
TEAEs, n (%) 35 (100) 15 (100) 
Grade ≥3 35 (100) 15 (100) 
Study drug related  29 (83) NA 
Treatment-emergent SAEs, n (%) 25 (71) 11 (73) 
Grade ≥3 25 (71) 11 (73) 
Study drug related  18 (51) NA 
TEAEs leading to ibrutinib discontinuation, n (%) 1 (3) NA 
TEAEs leading to RICE/RVICI discontinuation,§ n (%) 4 (11) 
TEAEs with outcome of death, n (%) 4 (11) 2 (13) 
Ibrutinib plus RICE/RVICI (n = 35)RICE/RVICI (n = 15)
TEAEs, n (%) 35 (100) 15 (100) 
Grade ≥3 35 (100) 15 (100) 
Study drug related  29 (83) NA 
Treatment-emergent SAEs, n (%) 25 (71) 11 (73) 
Grade ≥3 25 (71) 11 (73) 
Study drug related  18 (51) NA 
TEAEs leading to ibrutinib discontinuation, n (%) 1 (3) NA 
TEAEs leading to RICE/RVICI discontinuation,§ n (%) 4 (11) 
TEAEs with outcome of death, n (%) 4 (11) 2 (13) 

NA, not applicable.

TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication.

Based on all patients who received at least 1 dose of study treatment.

This row is applicable to ibrutinib only.

§

Refers to discontinuation of any component of RICE/RVICI.

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