Table 2.
Adverse Event | 30 d Post Treatment |
90 d Post Treatment |
||||||||
---|---|---|---|---|---|---|---|---|---|---|
SBRT | Grade III/IV | Surgery | Grade III/IV | P Value* | SBRT | Grade III/IV | Surgery | Grade III/IV | P Value* | |
No. (%)† | No. (%)‡ | No. (%)† | No. (%)‡ | No. (%)† | No. (%)‡ | No. (%)† | No. (%)‡ | |||
At least 1 AE | 42 (25.6) | 6 (14.2) | 26 (29.6) | 3 (11.5) | 0.50 | 56 (34.2) | 6 (10.7) | 30 (34.1) | 3 (10.0) | 0.99 |
Constitutional | 29 (17.7) | 0 (0.0) | 7 (8.0) | 0 (0.0) | 0.04 | 35 (21.3) | 0 (0.0) | 8 (9.1) | 0 (0.0) | 0.01 |
Respiratory | 15 (41.7) | 2 (13.3) | 21 (58.3) | 1 (4.8) | <0.01 | 21 (46.7) | 3 (14.3) | 24 (53.3) | 1 (4.1) | <0.01 |
Infectious | 1 (0.6) | 0 (0.0) | 7 (8.0) | 2 (28.5) | <0.01 | 7 (4.3) | 2 (28.5) | 7 (8.0) | 2 (28.5) | 0.25 |
Cardiovascular | 1 (0.6) | 1 (100.0) | 2 (2.3) | 0 (0.0) | 0.28 | 1 (0.6) | 1 (100.0) | 4 (4.6) | 0 (0.0) | 0.05 |
Cutaneous | 3 (1.8) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 0.55 | 4 (2.4) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0.30 |
Musculoskeletal | 4 (2.4) | 1 (25.0) | 2 (2.3) | 0 (0.0) | 0.99 | 5 (3.1) | 1 (20.0) | 2 (2.3) | 0 (0.0) | 0.99 |
Gastrointestinal | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.99 | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.99 |
Neurological | 1 (0.6) | 1 (100.0) | 0 (0.0) | 0 (0.0) | 0.99 | 1 (0.6) | 1 (100.0) | 0 (0.0) | 0 (0.0) | 0.99 |
Hematological | 0 (0.0) | 0 (0.0) | 1 (1.1) | 0 (0.0) | 0.35 | 0 (0.0) | 0 (0.0) | 1 (1.1) | 0 (0.0) | 0.35 |
Definition of abbreviations: AE = adverse event; SBRT = stereotactic body radiation therapy.
P value compares the statistical significance for overall (i.e., all grades) AEs between SBRT vs. surgery.
Indicates the percentage of participants in the treatment group that experienced AEs of any level of severity.
Indicates percentage of the total AEs that were grade III or IV.