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The panel said such monitoring should be carried out just when there are scientific reasons for suspecting the possibility of long-term or delayed toxicity.
The hypothesis of delayed toxicity in cold freshwaters is viable based on a review of available literature; this hypothesis should be tested.
Animals that survived after 24 h were observed for any signs of delayed toxicity for 2 weeks.
Animals that survived after 24 h were observed for any signs of delayed toxicity for two weeks.
In respect of acute toxicity, the extract did not produce any mortality and visible signs of delayed toxicity administered i.p. up to 2 g/kg.
Individual animal was kept in close observation during the first 30 min after dosing, periodically first 24 h (special attention for the first 4 h), thereafter for a period of 3 days to record the delayed toxicity.
Similar(20)
Six of the seven treated patients developed delayed toxicities mainly due to the cytokine elevation related to CART-20 cells 3 8 weeks post-CART-20 cells infusion, except for a grade 4 acute alimentary tract hemorrhage resulting in death.
Patients were monitored for immediate and delayed toxicities.
First, data regarding delayed toxicities, including disease progression, were prospectively collected for our secondary endpoints.
Acute or delayed toxicities of treatment will be documented in the eCRF.
The DLT window required expansion to 42 days (1.5 cycles) to capture delayed toxicities.
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