Table 2.
Adverse events higher than grade 1 reported in ≥5% of patients in the phase 1b/2 study
| Adverse Event | 0–3 wk (n = 56) No. Patients (%) |
4–8 wk (n = 53) No. Patients (%) |
||
|---|---|---|---|---|
| Grade > 1 | Grade > 2 | Grade > 1 | Grade > 2 | |
| Constitutional Symptoms- any | 10 (18) | 1 (2) | 10 (19) | – |
| Fatigue | 4 (7) | – | 6 (11) | – |
| Insomnia | 4 (7) | 1 (2) | 4 (8) | – |
| Dermatology/skin- any | – | – | 5 (9) | 1 (2) |
| Gastrointestinal- any | 7 (13) | – | 5 (9) | – |
| Anorexia | 4 (7) | – | 1 (2) | – |
| Constipation | 1 (2) | – | 3 (6) | – |
| Infection- any | 3 (5) | – | 2 (4) | 1 (2) |
| Urinary tract infection | 3 (5) | – | 1 (2) | – |
| Neurology- any | 26 (46) | 9 (16) | 12 (23) | 3 (6) |
| Mood alteration–depression | 4 (7) | 1 (2) | 2 (4) | – |
| Neuropathy–Motor | 6 (11) | 3 (5) | 1 (2) | – |
| Seizure | 3 (5) | 1 (2) | 3 (6) | 1 (2) |
| Speech impairment | 5 (9) | 1 (2) | 3 (6) | – |
| Ocular- any | 3 (5) | 1 (2) | – | – |
| Pain- any | 10 (18) | 2 (4) | 4 (8) | 1 (2) |
| Headache | 9 (16) | 2 (4) | 2 (4) | 1 (2) |
| Vascular- any | 3 (5) | 2 (4) | 3 (6) | 3 (6) |
| Thrombosis Embolism | 3 (5) | 2 (4) | 3 (6) | 3 (6) |
| Laboratory | ||||
| Elevated AST/ALT | 5 (9) | 3 (5) | 2 (4) | – |
| Low calcium | 3 (5) | – | 1 (2) | – |
| Low hemoglobin | 3 (5) | 1 (2) | 2 (4) | – |
| Low lymphocytes | 8 (14) | 2 (4) | 17 (32) | 7 (13) |
Abbreviations: ALT, alanine amino transferase; AST, aspartate aminotransferase.
Events during the 0–3 week period occurring after surgery and AdV-tk, aglatimagene besadenovec injection, during the 14 days of prodrug administration, and up to 2 weeks of radiation. Events during the 4–8 week period occurred during the follow-on radiation period and concomitant temozolomide administration. Grading is based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0