Table 2.
Treatment-related and unexpected grade ≥3 adverse events through day 90
| Event | Arm 1 (n=21)
|
Arm 2 (n=23)
|
P value | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade
|
No. of events (%)
|
Grade
|
No. of events (%)
|
||||||||
| 1 | 2 | 3 | 4 | Total | 1 | 2 | 3 | 4 | Total | ||
| Blood/bone marrow | |||||||||||
| Anemia | 4 (19%) | 4 (19%) | 9 (39%) | 9 (39%) | .19 | ||||||
| Leukopenia | 6 (29%) | 4 (19%) | 10 (48%) | 5 (22%) | 1 (4%) | 6 (26%) | .19 | ||||
| Lymphopenia | 4 (19%) | 11 (52%) | 5 (24%) | 20 (95%) | 5 (22%) | 10 (43%) | 2 (9%) | 17 (74%) | .20 | ||
| Neutropenia | 4 (19%) | 2 (10%) | 1 (5%) | 7 (33%) | 1 (4%) | 1 (4%) | .03 | ||||
| Thrombocytopenia | 9 (43%) | 1 (5%) | 10 (48%) | 3 (13%) | 3 (13%) | .03 | |||||
| Cardiac | |||||||||||
| Right bundle block | 1 (5%) | 1 (5%) | 0 (0%) | .48 | |||||||
| Hypertension | 0 (0%) | 2 (9%) | 2 (9%) | .49 | |||||||
| Coagulation | |||||||||||
| PTT | 0 (0%) | 1 (4%) | 1 (4%) | >.99 | |||||||
| Constitutional | |||||||||||
| Fatigue | 12 (57%) | 5 (24%) | 17 (81%) | 14 (61%) | 1 (4%) | 1 (4%) | 16 (70%) | .20 | |||
| Gastrointestinal* | 11 (52%) | 1 (5%) | 12 (57%) | 11 (48%) | 2 (9%) | 13 (57%) | >.99 | ||||
| Genitourinary* | 6 (29%) | 8 (38%) | 1 (5%) | 15 (71%) | 11 (48%) | 5 (22%) | 2 (9%) | 18 (78%) | .53 | ||
| Urinary retention | 11 (52%) | 1 (5%) | 12 (57%) | 8 (35%) | 1 (4%) | 9 (39%) | .28 | ||||
| Metabolic/laboratory | |||||||||||
| ALT (SGPT) | 9 (43%) | 1 (5%) | 10 (48%) | 0 (0%) | <.01 | ||||||
| AST (SGOT) | 8 (38%) | 3 (14%) | 11 (52%) | 2 (9%) | 2 (9%) | <.01 | |||||
| CPK | 0 (0%) | 1 (4%) | 1 (4%) | >.99 | |||||||
| Hyperglycemia | 1 (5%) | 1 (5%) | 0 (0%) | .48 | |||||||
| Hypermagnesemia | 1 (5%) | 1 (5%) | 0 (0%) | .48 | |||||||
| Hypophosphatemia | 1 (5%) | 1 (5%) | 0 (0%) | .48 | |||||||
| Respiratory | |||||||||||
| Pneumonitis (NOS) | 1 (5%) | 1 (5%) | 0 (0%) | .48 | |||||||
| Syndromes | |||||||||||
| Influenza-like | 15 (71%) | 1 (5%) | 16 (76%) | 1 (4%) | 1 (4%) | <.01 | |||||
| Vascular | |||||||||||
| Deep vein thrombosis | 1 (5%) | 1 (5%) | 0 (0%) | .48 | |||||||
| Pulmonary embolism | 1 (5%) | 1 (5%) | 0 (0%) | .48 | |||||||
| Totals | 99 (66%) | 38 (25%) | 13 (9%) | 1 (1%) | 151 (100%) | 69 (70%) | 20 (20%) | 10 (10%) | 0 (0%) | 99 (100%) | |
Abbreviations: ALT = XXXX; AST = androgen suppression therapy; CPK = XXXX; PTT = XXXX; SGOT = XXXX; SGPT = XXXX.
*
Gastrointestinal (GI) and genitourinary (GU) events were graded using the RTOG acute morbidity scoring criteria. GI events include diarrhea, rectal bleeding, and rectal pain. GU events include urinary frequency/urgency and dysuria. Urinary retention is not included in the RTOG acute GU morbidity scoring criteria and therefore is listed separately.