Table 4.
Adverse event data comparing TLPLDC and placeboa
| Adverse events | TLPLDC | Placebo | p value |
|---|---|---|---|
| Any AE | 69 (67.0) | 28 (68.3) | 0.880 |
| Serious AEb | 10 (9.7) | 6 (14.6) | 0.396 |
| Severe AE (grade 3 or higher)c | 12 (11.7) | 8 (19.5) | 0.218 |
| Related AEd | 37 (35.9) | 13 (31.7) | 0.632 |
| Related serious AE | 1 (1.0) | 1 (2.4) | 0.497 |
| Local adverse events | |||
| Injection site erythema | 17 (16.5) | 4 (9.8) | 0.300 |
| Skin induration | 11 (10.7) | 4 (9.8) | 0.870 |
| Systemic adverse events | |||
| Fatigue | 14 (13.6) | 5 (12.2) | 0.823 |
| Headache | 10 (9.7) | 3 (7.3) | 0.651 |
| Diarrhea | 10 (9.7) | 2 (4.9) | 0.344 |
| Cough | 7 (6.8) | 4 (9.8) | 0.546 |
| Fever | 5 (4.9) | 4 (9.8) | 0.273 |
| Hypertension | 5 (4.9) | 3 (7.3) | 0.560 |
| Nausea | 5 (4.9) | 3 (7.3) | 0.560 |
Data are expressed as n (%)
TLPLDC tumor lysate, particle-loaded, dendritic cell, AE adverse event, CTCAE Common Terminology Criteria for Adverse Events
aSpecific adverse events are categorized by Preferred Term
bDefined as resulting in death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, a congenital anomaly/birth defect, or requiring medical or surgical intervention to prevent one of these outcomes
cDefined as grade 3 or higher according to the CTCAE version 4.03
dAEs classified as possibly, probably, and definitely related are included in related AEs