Table 3.

Summary of AEs

Event, n (%)Patients who received idelalisib as the last prior BCRi
Main cohort (n = 21)Expansion cohort (n = 15)All patients (N = 36)
Any grade AE in 20% or more of all patients    
 All reported AEs 21 (100) 15 (100) 36 (100) 
  Neutropenia* 11 (52) 9 (60) 20 (56) 
  Diarrhea 9 (43) 6 (40) 15 (42) 
  Upper respiratory tract infection 6 (29) 8 (53) 14 (39) 
  Thrombocytopenia 7 (33) 6 (40) 13 (36) 
  Nausea 6 (29) 5 (33) 11 (31) 
  Fatigue 6 (29) 4 (27) 10 (28) 
  Rash 6 (29) 2 (13) 8 (22) 
  Anemia 4 (19) 4 (27) 8 (22) 
  Cough 4 (19) 4 (27) 8 (22) 
Grade 3 or 4 AEs in 10% or more of all patients    
 All reported grade 3 or 4 AEs 17 (81) 10 (67) 27 (75) 
  Neutropenia* 10 (48) 8 (53) 18 (50) 
  Thrombocytopenia 6 (29) 3 (20) 9 (25) 
  Anemia 3 (14) 3 (20) 6 (17) 
  Hypokalemia 1 (5) 3 (20) 4 (11) 
Serious AEs in 5% or more of all patients    
 All serious AES 10 (48) 5 (33) 15 (42) 
  Pneumonia 2 (10) 2 (6) 
  Cholecystitis or cholecystitis acute 2 (10) 2 (6) 
Event, n (%)Patients who received idelalisib as the last prior BCRi
Main cohort (n = 21)Expansion cohort (n = 15)All patients (N = 36)
Any grade AE in 20% or more of all patients    
 All reported AEs 21 (100) 15 (100) 36 (100) 
  Neutropenia* 11 (52) 9 (60) 20 (56) 
  Diarrhea 9 (43) 6 (40) 15 (42) 
  Upper respiratory tract infection 6 (29) 8 (53) 14 (39) 
  Thrombocytopenia 7 (33) 6 (40) 13 (36) 
  Nausea 6 (29) 5 (33) 11 (31) 
  Fatigue 6 (29) 4 (27) 10 (28) 
  Rash 6 (29) 2 (13) 8 (22) 
  Anemia 4 (19) 4 (27) 8 (22) 
  Cough 4 (19) 4 (27) 8 (22) 
Grade 3 or 4 AEs in 10% or more of all patients    
 All reported grade 3 or 4 AEs 17 (81) 10 (67) 27 (75) 
  Neutropenia* 10 (48) 8 (53) 18 (50) 
  Thrombocytopenia 6 (29) 3 (20) 9 (25) 
  Anemia 3 (14) 3 (20) 6 (17) 
  Hypokalemia 1 (5) 3 (20) 4 (11) 
Serious AEs in 5% or more of all patients    
 All serious AES 10 (48) 5 (33) 15 (42) 
  Pneumonia 2 (10) 2 (6) 
  Cholecystitis or cholecystitis acute 2 (10) 2 (6) 

AE, adverse event.

*

Neutropenia included the preferred terms of neutropenia and decreased neutrophil count.

Thrombocytopenia included the preferred terms of thrombocytopenia and decreased platelet count.

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