TABLE 3.
Laboratory-based AEs | ||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hematology | Kidney | Liver | Pancreatobiliary | |||||||||||||||||||||
WBCs | ANC | Hb | PLTs | sCr | T Bil | AST | ALT | GGT | ALP | Amylase | New G3/G4 AE (laboratory) | |||||||||||||
Patient no. | General | B | F | B | F | B | F | B | F | B | F | B | F | B | F | B | F | B | F | B | F | B | F | |
1 | Acute respiratory distress, tumor-related (G5) | — | — | — | — | G3 | G2 | — | G3 | — | — | — | — | — | — | — | — | G2 | G1 | G1 | — | — | — | Yes |
2 | Tumor pain (G2) | — | — | — | — | — | G1 | — | G1 | — | — | — | — | — | — | — | — | G1 | G1 | G1 | G1 | — | — | No |
3 | None | — | — | — | — | — | — | — | G1 | — | — | — | — | — | — | — | — | G1 | G1 | G1 | G1 | — | — | No |
4 | Tumor progression, (G5) | G1 | G2 | — | G1 | G3 | G3 | G1 | G3 | — | G2 | — | G3 | — | G1 | — | — | G1 | G3 | G2 | G2 | — | — | Yes |
5 | Tumor progression (G5) | — | — | — | — | G1 | G2 | G1 | G3 | — | G1 | — | G2 | G2 | G4 | G1 | G4 | G3 | G4 | G3 | G3 | — | — | Yes |
6 | Pneumonia*, tumor progression (G5) | — | — | — | — | G1 | G3 | G1 | G3 | — | G2 | — | G2 | — | G2 | — | — | G3 | — | G1 | G2 | — | — | Yes |
7 | Fever, urinary tract infection* | — | — | — | — | G1 | G2 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | No |
8 | None | — | — | — | — | G1 | — | — | — | — | — | — | — | — | — | — | — | — | G1 | G1 | G1 | — | — | No |
9 | None | — | — | — | — | G1 | G1 | — | — | — | — | — | — | — | — | — | — | G3 | G3 | G2 | G2 | — | — | No |
Any new AE (%) | 1 (11%) | 1 (11%) | 3 (33%) | 6 (67%) | 3 (33%) | 3 (33%) | 3 (33%) | 1 (11%) | 3 (33%) | 1 (11%) | — | |||||||||||||
Any new G3/G4 AE (%) | — | — | 1 (11%) | 4 (44%) | — | 1 (11%) | 1 (11%) | 1 (11%) | 2 (22%) | — | — |
Relation to 90Y-FAPI-46 was ruled out.
AE = adverse event; WBCs = white blood cells; ANC = absolute neutrophil count; Hb = hemoglobin; PLTs = platelets (thrombocytes); sCr = serum creatinine; T Bil = total bilirubin; AST = aspartate transaminase; ALT = alanine transaminase; GGT = γ-glutamyltransferase; ALP = alkaline phosphatase; B = baseline; F = follow-up.
G grade is defined as per CTCAE, version 5.0.