TEAEs (≥10% any-grade and all grade 3/4)
| . | All treated (n = 97)* . | Avadomide HCl . | Avadomide . | |||||
|---|---|---|---|---|---|---|---|---|
| 3 mg 28/28 days (n = 25)† . | 4 mg 5/7 days (n = 39) . | 3 mg 5/7 days (n = 18) . | ||||||
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| At least 1 TEAE | 97 (100) | 82 (85) | 25 (100) | 21 (84) | 39 (100) | 32 (82) | 18 (100) | 14 (78) |
| Neutropenia | 64 (66) | 49 (51) | 19 (76) | 16 (64) | 24 (62) | 15 (39) | 10 (56) | 7 (39) |
| Infections and infestations | 55 (57) | 23 (24) | 15 (60) | 8 (32) | 22 (56) | 7 (18) | 9 (50) | 3 (17) |
| Asthenia | 45 (46) | 7 (7) | 14 (56) | 4 (16) | 17 (44) | 2 (5) | 8 (44) | 1 (6) |
| Pyrexia | 37 (38) | 1 (1) | 11 (44) | 0 | 18 (46) | 0 | 4 (22) | 1 (6) |
| Anemia | 34 (35) | 12 (12) | 12 (48) | 5 (20) | 12 (31) | 5 (13) | 5 (28) | 1 (6) |
| Cough | 33 (34) | 0 | 11 (44) | 0 | 9 (23) | 0 | 5 (28) | 0 |
| Constipation | 25 (26) | 0 | 4 (16) | 0 | 11 (28) | 0 | 4 (22) | 0 |
| Edema peripheral | 22 (23) | 3 (3) | 7 (28) | 2 (8) | 9 (23) | 1 (3) | 2 (11) | 0 |
| Thrombocytopenia | 22 (23) | 7 (7) | 9 (36) | 3 (12) | 8 (21) | 3 (8) | 3 (17) | 0 |
| Diarrhea | 18 (19) | 0 | 5 (20) | 0 | 3 (8) | 0 | 4 (22) | 0 |
| Dyspnea | 18 (19) | 6 (6) | 4 (16) | 1 (4) | 9 (23) | 3 (8) | 3 (17) | 2 (11) |
| Nausea | 18 (19) | 0 | 4 (16) | 0 | 10 (26) | 0 | 2 (11) | 0 |
| Decreased appetite | 15 (16) | 2 (2) | 4 (16) | 1 (4) | 6 (15) | 0 | 1 (6) | 1 (6) |
| Vomiting | 15 (16) | 1 (1) | 3 (12) | 0 | 7 (18) | 0 | 1 (6) | 0 |
| General physical health deterioration | 14 (14) | 6 (6) | 2 (8) | 1 (4) | 7 (18) | 3 (8) | 3 (17) | 2 (11) |
| Back pain | 12 (12) | 1 (1) | 2 (8) | 0 | 4 (10) | 0 | 2 (11) | 0 |
| Fatigue | 12 (12) | 3 (3) | 1 (4) | 0 | 6 (15) | 2 (5) | 4 (22) | 1 (6) |
| Abdominal pain | 11 (11) | 0 | 3 (12) | 0 | 2 (5) | 0 | 3 (17) | 0 |
| Febrile neutropenia | 10 (10) | 10 (10) | 3 (12) | 3 (12) | 2 (5) | 2 (5) | 0 | 0 |
| Rash maculopapular | 10 (10) | 1 (1) | 1 (4) | 0 | 5 (13) | 1 (3) | 2 (11) | 0 |
| Tumor flare | 10 (10) | 1 (1) | 1 (4) | 0 | 7 (18) | 1 (3) | 0 | 0 |
| . | All treated (n = 97)* . | Avadomide HCl . | Avadomide . | |||||
|---|---|---|---|---|---|---|---|---|
| 3 mg 28/28 days (n = 25)† . | 4 mg 5/7 days (n = 39) . | 3 mg 5/7 days (n = 18) . | ||||||
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| At least 1 TEAE | 97 (100) | 82 (85) | 25 (100) | 21 (84) | 39 (100) | 32 (82) | 18 (100) | 14 (78) |
| Neutropenia | 64 (66) | 49 (51) | 19 (76) | 16 (64) | 24 (62) | 15 (39) | 10 (56) | 7 (39) |
| Infections and infestations | 55 (57) | 23 (24) | 15 (60) | 8 (32) | 22 (56) | 7 (18) | 9 (50) | 3 (17) |
| Asthenia | 45 (46) | 7 (7) | 14 (56) | 4 (16) | 17 (44) | 2 (5) | 8 (44) | 1 (6) |
| Pyrexia | 37 (38) | 1 (1) | 11 (44) | 0 | 18 (46) | 0 | 4 (22) | 1 (6) |
| Anemia | 34 (35) | 12 (12) | 12 (48) | 5 (20) | 12 (31) | 5 (13) | 5 (28) | 1 (6) |
| Cough | 33 (34) | 0 | 11 (44) | 0 | 9 (23) | 0 | 5 (28) | 0 |
| Constipation | 25 (26) | 0 | 4 (16) | 0 | 11 (28) | 0 | 4 (22) | 0 |
| Edema peripheral | 22 (23) | 3 (3) | 7 (28) | 2 (8) | 9 (23) | 1 (3) | 2 (11) | 0 |
| Thrombocytopenia | 22 (23) | 7 (7) | 9 (36) | 3 (12) | 8 (21) | 3 (8) | 3 (17) | 0 |
| Diarrhea | 18 (19) | 0 | 5 (20) | 0 | 3 (8) | 0 | 4 (22) | 0 |
| Dyspnea | 18 (19) | 6 (6) | 4 (16) | 1 (4) | 9 (23) | 3 (8) | 3 (17) | 2 (11) |
| Nausea | 18 (19) | 0 | 4 (16) | 0 | 10 (26) | 0 | 2 (11) | 0 |
| Decreased appetite | 15 (16) | 2 (2) | 4 (16) | 1 (4) | 6 (15) | 0 | 1 (6) | 1 (6) |
| Vomiting | 15 (16) | 1 (1) | 3 (12) | 0 | 7 (18) | 0 | 1 (6) | 0 |
| General physical health deterioration | 14 (14) | 6 (6) | 2 (8) | 1 (4) | 7 (18) | 3 (8) | 3 (17) | 2 (11) |
| Back pain | 12 (12) | 1 (1) | 2 (8) | 0 | 4 (10) | 0 | 2 (11) | 0 |
| Fatigue | 12 (12) | 3 (3) | 1 (4) | 0 | 6 (15) | 2 (5) | 4 (22) | 1 (6) |
| Abdominal pain | 11 (11) | 0 | 3 (12) | 0 | 2 (5) | 0 | 3 (17) | 0 |
| Febrile neutropenia | 10 (10) | 10 (10) | 3 (12) | 3 (12) | 2 (5) | 2 (5) | 0 | 0 |
| Rash maculopapular | 10 (10) | 1 (1) | 1 (4) | 0 | 5 (13) | 1 (3) | 2 (11) | 0 |
| Tumor flare | 10 (10) | 1 (1) | 1 (4) | 0 | 7 (18) | 1 (3) | 0 | 0 |
Data are presented as n (%) of patients. AEs were coded using MedRA (version 20.1 or higher) and are listed as preferred terms except infections and infestations, which is the combined system, organ, class.
TEAE, treatment-emergent AE.
One subject with DLBCL from the avadomide HCl 3-mg 28/28-day cohort discontinued and reentered the study with a new ID and treatment regimen (avadomide 3 mg 5/7 days). These 2 IDs are counted as separate subjects in the safety analysis.
One subject from the avadomide HCl 3-mg 28/28-day cohort was treated for mantle cell lymphoma and did not have DLBCL.