Table 2

Overall summary of AES by baseline CrCl levels and histology subtype

Patients with ≥1 indicated AEAll treated patients
(n=214)
Baseline CrCl, mL/minHistology type
MVH component (n=24)*
<30
(n=13)
30–45
(n=37)
45–60
(n=52)
≥60
(n=111)
UC
(n=190)
UC with MVH
(n=24)
Adeno carcinoma
(n=3)
Squamous
(n=8)
Sarco matoid
(n=3)
Other
(n=10)†
Total deaths, n5841112315260312
AESIs, n (%)59 (28)2 (15)9 (24)13 (25)35 (32)52 (27)7 (29)01 (13)06 (60)
 Renal AESIs2 (0.9)001 (1.9)‡1 (0.9)‡
Treatment-related AEs, n (%)
 Any grade98 (46)5 (38)13 (35)28 (54)52 (47)87 (46)11 (46)1 (33)2 (25)1 (33)7 (70)
 Renal AEs5 (2.3)02 (5.4)§1 (1.9)‡2 (1.8)‡¶
 Serious AEs11 (5.1)2 (15)2 (5.4)4 (7.7)3 (2.7)10 (5.3)1 (4.2)001 (33)0
 Serious renal AEs1 (0.47)01 (2.7)§00
 AEs leading to treatment discontinuation**4 (1.9)001 (1.9)3 (2.7)4 (2.1)00000
  • Renal AEs not shown for histology subgroups.

  • *For patients with UC with MVH (predominantly UC with another histology component).

  • †“Other” component for patients with UC with MVH includes UC with unspecified mixed histology, papillary (n=2 each) and squamous/glandular differentiation, glandular, sarcomatoid/rhabdoid differentiation, micropapillary, micropapillary features, micropapillary/glandular/squamous (n=1 each).

  • ‡Immune-related nephritis.

  • §Acute kidney injury.

  • ¶Proteinuria.

  • **Based on primary reason of study treatment discontinuation noted in the treatment discontinuation form.

  • AE, adverse event; AESI, AE of special interest; CrCl, creatinine clearance; MVH, mixed variant histology; UC, urothelial carcinoma.