Accurate and timely evaluation of AEs on ClinT is critical to assure patient (pt) safety. In PM ClinT toxicity is captured in real time with AEs assessed by a ClinT nurse, standardized with CTCAE and electronically sourced, and approved by a physician.
AEs recorded in the PM ClinT AE database between 01/2016 and 12/2018 were evaluated. Gyne ClinT assessing systemic therapy were included. Inferential statistics on risk factors of grade ≥ 3 (G3+) AE reporting and GEE logistic models with Odds Ratios (OR) were performed. Multivariate (m/v) analysis was adjusted to age, ClinT phase, sponsor, therapy combination and type.
We identified 516 ClinT with 3,467 pts on therapy. Among them, 42 ClinT were launched in the gyne site (52% ovarian, 10% uterine, 10% cervix, 28% multiple). 317 unique pts were accrued in gyne ClinT (38 pt in >1ClinT [range 1–4 ClinT]), yielding 362 pts on therapy (Table). 17,187 AEs were reported, 10.6% were grade ≥3 (G3+), 0.9% G4+ and 0.02% G5 . The most common G3+ AEs were hematological (49%), gastro-intestinal (13%). On m/v analysis, no odds differences of G3+ AEs were detected according to study phase. Pts enrolled in immunotherapy ClinT had lower odds of G3+ AE than pts on targeted or other therapy (OR 0.55; 0.32-0.96). There was greater odds of G3+ AEs in ClinT assessing combination vs single therapeutics (OR 2.27; 1.40-3.69), and in investigator initiated ClinT vs not (OR 2.29; 1.24-4.23). Pts aged <50 (OR 2.13; 1.01-4.48) and >65 (OR 1.72; 1.03-2.83) had greater odds of G3+ AEs than pts aged 50 to 65 years. Overall, when compared to other disease sites, the odds of having a G3+ AE reported in gyne ClinT was no different, but the odds of G4+ AEs (OR 0.54; 0.38-0.74) and G5 AEs (OR 0.08; 0.01-0.26) was lower.
| Category | N of subjects | |
| Phase | I/II | 246 (68%) |
| III | 116 (32%) | |
| Age | Median | 60.7 years; 23 to 81.5 years |
| Investigational intervention | Immunotherapy | 86 (24%) |
| Targeted therapy | 255 (70%) | |
| Other | 21 (6%) | |
| Therapy Combination | Yes | 194 (54%) |
| Investigator Initiated | Yes | 74 (21%) |
| Days to G3+ AE onset | Median | 54.9 days; 0 to 1,540 days |
In gyne ClinT the odds of having a G3+ AE reported were more frequent on combination therapy studies and investigator initiated trials. Lower odds of having G3+ AEs were detected in immunotherapy trials and pts aged 50-65.