Introduction: The previously reported SANET-ep trial (NCT02588170) demonstrated surufatinib significantly improves progression-free survival (PFS) in patients (pts) with advanced extrapancreatic neuroendocrine tumors (epNETs) compared to placebo; median PFS (9.2 vs. 3.8 months; HR = 0.334, 95% CI 0.223 to 0.499, p
Aim(s): The present analysis evaluates the safety profile and adverse events of special interest (AESIs) of surufatinib from SANET-ep data.
Materials and methods: Pts were randomized (2:1) to receive surufatinib (300 mg once daily continuously) or placebo. Treatment-related AESIs and time-to-first occurrence of AESIs were summarized. Predefined AESIs included hepatic failure (HF), proteinuria (P), hypertension (HTN), haemorrhage (H), and acute renal failure (ARF), which were searched with narrow MedDRA Standardized MedDRA Query (SMQ).
Conference: 17th Annual ENETS Conference 2020 (2020)
Category: Medical treatment - Targeted therapies
Presenting Author: Jie Li
, Xu J
, Zhou Z
, Bai C
, Chi Y
, Li Z
, Xu N
, Li E
, Liu T
, Bai Y
, Guan S
, Shen L
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