Drug-related grade 3 or 4 adverse events in at least 5% of the patients
| Body system (dictionary-derived term) . | BSC (n = 229) . | Tipifarnib (n = 225) . | ||||
|---|---|---|---|---|---|---|
| Total, n (%) . | Toxicity grade, n (%) . | Total, n (%) . | Toxicity grade, n (%) . | |||
| 3 . | 4 . | 3 . | 4 . | |||
| Patients with an adverse event | 172 (75) | 202 (90) | ||||
| Blood and lymphatic system disorders | 100 (44) | 36 (16) | 64 (28) | 140 (62) | 41 (18) | 99 (44) |
| Thrombocytopenia | 61 (27) | 30 (13) | 31 (14) | 88 (39) | 35 (16) | 53 (24) |
| Anemia | 58 (25) | 39 (17) | 19 (8) | 75 (33) | 47 (21) | 28 (12) |
| Neutropenia | 35 (15) | 10 (4) | 25 (11) | 56 (25) | 10 (4) | 46 (20) |
| Febrile neutropenia | 24 (10) | 19 (8) | 5 (2) | 37 (16) | 28 (12) | 9 (4) |
| Leukopenia | 19 (8) | 8 (3) | 11 (5) | 25 (11) | 6 (3) | 19 (8) |
| Infections and infestations | 76 (33) | 55 (24) | 21 (9) | 87 (39) | 61 (27) | 26 (12) |
| Pneumonia | 43 (19) | 33 (14) | 10 (4) | 38 (17) | 29 (13) | 9 (4) |
| Sepsis | 19 (8) | 8 (3) | 11 (5) | 32 (14) | 18 (8) | 14 (6) |
| Metabolism and nutrition disorders | 22 (10) | 15 (7) | 7 (3) | 54 (24) | 40 (18) | 14 (6) |
| Hypokalemia | 13 (6) | 10 (4) | 3 (1) | 37 (16) | 28 (12) | 9 (4) |
| General disorders and administration site conditions | 46 (20) | 40 (17) | 6 (3) | 48 (21) | 42 (19) | 6 (3) |
| Fatigue | 29 (13) | 25 (11) | 4 (2) | 31 (14) | 28 (12) | 3 (1) |
| Pyrexia | 15 (7) | 14 (6) | 1 (< 1) | 11 (5) | 11 (5) | 0 |
| Gastrointestinal disorders | 20 (9) | 18 (8) | 2 (1) | 42 (19) | 39 (17) | 3 (1) |
| Diarrhea | 0 | 0 | 0 | 16 (7) | 16 (7) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 27 (12) | 15 (7) | 12 (5) | 28 (12) | 20 (9) | 8 (4) |
| Dyspnea | 12 (5) | 8 (3) | 4 (2) | 9 (4) | 7 (3) | 2 (1) |
| Cardiac disorders | 33 (14) | 13 (6) | 20 (9) | 25 (11) | 7 (3) | 18 (8) |
| Cardiac failure | 17 (7) | 4 (2) | 13 (6) | 12 (5) | 2 (1) | 10 (4) |
| Body system (dictionary-derived term) . | BSC (n = 229) . | Tipifarnib (n = 225) . | ||||
|---|---|---|---|---|---|---|
| Total, n (%) . | Toxicity grade, n (%) . | Total, n (%) . | Toxicity grade, n (%) . | |||
| 3 . | 4 . | 3 . | 4 . | |||
| Patients with an adverse event | 172 (75) | 202 (90) | ||||
| Blood and lymphatic system disorders | 100 (44) | 36 (16) | 64 (28) | 140 (62) | 41 (18) | 99 (44) |
| Thrombocytopenia | 61 (27) | 30 (13) | 31 (14) | 88 (39) | 35 (16) | 53 (24) |
| Anemia | 58 (25) | 39 (17) | 19 (8) | 75 (33) | 47 (21) | 28 (12) |
| Neutropenia | 35 (15) | 10 (4) | 25 (11) | 56 (25) | 10 (4) | 46 (20) |
| Febrile neutropenia | 24 (10) | 19 (8) | 5 (2) | 37 (16) | 28 (12) | 9 (4) |
| Leukopenia | 19 (8) | 8 (3) | 11 (5) | 25 (11) | 6 (3) | 19 (8) |
| Infections and infestations | 76 (33) | 55 (24) | 21 (9) | 87 (39) | 61 (27) | 26 (12) |
| Pneumonia | 43 (19) | 33 (14) | 10 (4) | 38 (17) | 29 (13) | 9 (4) |
| Sepsis | 19 (8) | 8 (3) | 11 (5) | 32 (14) | 18 (8) | 14 (6) |
| Metabolism and nutrition disorders | 22 (10) | 15 (7) | 7 (3) | 54 (24) | 40 (18) | 14 (6) |
| Hypokalemia | 13 (6) | 10 (4) | 3 (1) | 37 (16) | 28 (12) | 9 (4) |
| General disorders and administration site conditions | 46 (20) | 40 (17) | 6 (3) | 48 (21) | 42 (19) | 6 (3) |
| Fatigue | 29 (13) | 25 (11) | 4 (2) | 31 (14) | 28 (12) | 3 (1) |
| Pyrexia | 15 (7) | 14 (6) | 1 (< 1) | 11 (5) | 11 (5) | 0 |
| Gastrointestinal disorders | 20 (9) | 18 (8) | 2 (1) | 42 (19) | 39 (17) | 3 (1) |
| Diarrhea | 0 | 0 | 0 | 16 (7) | 16 (7) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 27 (12) | 15 (7) | 12 (5) | 28 (12) | 20 (9) | 8 (4) |
| Dyspnea | 12 (5) | 8 (3) | 4 (2) | 9 (4) | 7 (3) | 2 (1) |
| Cardiac disorders | 33 (14) | 13 (6) | 20 (9) | 25 (11) | 7 (3) | 18 (8) |
| Cardiac failure | 17 (7) | 4 (2) | 13 (6) | 12 (5) | 2 (1) | 10 (4) |
Percentages in ″Total″ column for each group are calculated with the number of subjects in each group as the denominator. Percentages of toxicity grade subgroups are calculated with the number of subjects in each group as the denominator. Incidence is based on the number of patients, not the number of events.