Adverse events (safety population)
| Event . | Intensive pathway . | Nonintensive pathway . | Overall P† . | ||||
|---|---|---|---|---|---|---|---|
| Maintenance (n = 246)* . | No maintenance (n = 247) . | P . | Maintenance (n = 164)* . | No maintenance (n = 163) . | P . | ||
| Thromboembolic events | 4 (1.6) | 4 (1.6) | 1.0 | 3 (1.8) | 5 (3.1) | .50 | .80 |
| Any serious adverse event‡ | 60 (24.4) | 51 (20.6) | .33 | 56 (34.1) | 33 (20.2) | .0061 | .012 |
| No suspected association with study drugs | 48 (19.5) | 46 (18.6) | .82 | 43 (26.2) | 31 (19.0) | .15 | .26 |
| Any serious adverse reaction§ | 21 (8.5) | 7 (2.8) | .0064 | 16 (9.8) | 4 (2.5) | .0095 | .00014 |
| Hematologic disorders | 0 | 2 (0.8) | .50 | 0 | 0 | NA | .50 |
| Cardiovascular disorders | 2 (0.8) | 1 (0.4) | .62 | 4 (2.4) | 0 | .12 | .12 |
| Fluid and electrolyte disturbance | 0 | 0 | NA | 1 (0.6) | 0 | 1.0 | 1.0 |
| Gastrointestinal disorders | 2 (0.8) | 0 | .25 | 0 | 1 (0.6) | .50 | 1.0 |
| Infection | 6 (2.4) | 0 | .015 | 1 (0.6) | 1 (0.6) | 1.0 | .069 |
| Musculoskeletal, connective tissue, and bone disorders | 1 (0.4) | 3 (1.2) | .62 | 4 (2.4) | 0 | .12 | 1.0 |
| Nervous system disorders | 6 (2.4) | 1 (0.4) | .068 | 3 (1.8) | 2 (1.2) | 1.0 | .14 |
| Renal and urinary disorders | 3 (1.2) | 0 | .12 | 1 (0.6) | 0 | 1.0 | .12 |
| Reproductive system and breast disorders | 1 (0.4) | 0 | .50 | 0 | 0 | NA | 1.0 |
| Skin and subcutaneous disorders | 3 (1.2) | 0 | .12 | 2 (1.1) | 0 | .50 | .062 |
| Event . | Intensive pathway . | Nonintensive pathway . | Overall P† . | ||||
|---|---|---|---|---|---|---|---|
| Maintenance (n = 246)* . | No maintenance (n = 247) . | P . | Maintenance (n = 164)* . | No maintenance (n = 163) . | P . | ||
| Thromboembolic events | 4 (1.6) | 4 (1.6) | 1.0 | 3 (1.8) | 5 (3.1) | .50 | .80 |
| Any serious adverse event‡ | 60 (24.4) | 51 (20.6) | .33 | 56 (34.1) | 33 (20.2) | .0061 | .012 |
| No suspected association with study drugs | 48 (19.5) | 46 (18.6) | .82 | 43 (26.2) | 31 (19.0) | .15 | .26 |
| Any serious adverse reaction§ | 21 (8.5) | 7 (2.8) | .0064 | 16 (9.8) | 4 (2.5) | .0095 | .00014 |
| Hematologic disorders | 0 | 2 (0.8) | .50 | 0 | 0 | NA | .50 |
| Cardiovascular disorders | 2 (0.8) | 1 (0.4) | .62 | 4 (2.4) | 0 | .12 | .12 |
| Fluid and electrolyte disturbance | 0 | 0 | NA | 1 (0.6) | 0 | 1.0 | 1.0 |
| Gastrointestinal disorders | 2 (0.8) | 0 | .25 | 0 | 1 (0.6) | .50 | 1.0 |
| Infection | 6 (2.4) | 0 | .015 | 1 (0.6) | 1 (0.6) | 1.0 | .069 |
| Musculoskeletal, connective tissue, and bone disorders | 1 (0.4) | 3 (1.2) | .62 | 4 (2.4) | 0 | .12 | 1.0 |
| Nervous system disorders | 6 (2.4) | 1 (0.4) | .068 | 3 (1.8) | 2 (1.2) | 1.0 | .14 |
| Renal and urinary disorders | 3 (1.2) | 0 | .12 | 1 (0.6) | 0 | 1.0 | .12 |
| Reproductive system and breast disorders | 1 (0.4) | 0 | .50 | 0 | 0 | NA | 1.0 |
| Skin and subcutaneous disorders | 3 (1.2) | 0 | .12 | 2 (1.1) | 0 | .50 | .062 |
Data are n (%), unless stated otherwise. P values are based on Fisher exact test.
NA indicates not applicable.
Two patients randomized to receive maintenance who were excluded because no consent was received were included in the safety population.
P value for comparison of maintenance (n = 408) versus no maintenance (n = 410).
Irrespective of suspected association with study drugs; patients who had > 1 type of adverse event have been listed against all relevant types of events, but patients who had > 1 occurrence of the same type of event are recorded only once.
Suspected association with study drugs.