Oncology Oracle Questions Flashcards
In the BTC 01 Trial the most common grade 3 adverse reaction was_________
Anemia 13%
In the BTC 01 Trial the second most common grade 3 AE was _______
Diarrhea 9%
In the BTC 01 Trial the third most common grade 3 AE was ________
Increased ALT/AST 5%
In the BTC 01 Trial the fourth most common grade 4 AE was_______
Fatigue 4%
In BTC 01 the most common treatment emergent lab abnormality was_____
Low Hb 14%
BTC 01 the second most common treatment emergent lab abnormality was____
elevated ALT 8% and elevated AST 10%
BTC 01 the third most common treatment emergent lab abnormality was_______
Low sodium 10%
BTC 01 the fourth most common treatment emergent lab abnormality was _______
Low Lymphocytes 8%
In BTC 01 treatment emergent AE’s led to dose reductions in______ due to_______
4% patients, diarrhea (3%) nausea (1%) and decreased weight (1%).
In BTC 01 the discontinuation rate due to AE’s was _________
2.5%
BTC 01 AE’s leading to permanent discontinuation were______
Decreased ejection fraction 1.3% and Pneumonitis 1.3%
In BTC 01 Serious AE’s occurred in_____
13.8% and those that occurred in >2% included diarrhea (3%) and Fatigue (3%)
With respect to the primary endpoint the ORR by ICR was________
41.3%
In BTC 01 Did any patients experience a CR?
Yes, 2
Median Dor in BTC 01 was ____
14.9 months
In BTC 01 and Among those who were IHC 3+ and ISH amplified the cORR was____ and median DoR was____
52% and 15 months
In BTC 01and Among those who were IHC 2+ and ISH amplified the cORR was ____ and the median DoR was ______
6% and Not Evaluable
In BTC 01 and by AJCC how many were stage 4?
(71) 89%
BNTC 01 how many had greater than 1 prior line of therapy?
41%
BTC 01 How many had prior Gemcitabine therapy
(80) 100%