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Positive effects were reported in one phase II trial in patients with advanced ATC, which showed partial responses in 2 of 20 patients and stable disease in 5 of 20 patients [ 33].
18 Only solid malignancies were reported in one Phase III clinical trial, two cases of basal cell carcinoma and one case of prostate cancer in the group receiving a higher dose of golimumab (100 mg monthly) compared to no reports of malignancy in the lower golimumab dose (50 mg monthly) or placebo groups through week 24 of the study.
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One death due to a fulminant primary varicella zoster infection was reported in one of the phase III trials 40.
Hemolytic anemia was reported in one patient during the faldaprevir 24-week treatment phase.
In a phase I study of zanamivir, bronchospasm was reported in one out of 13 patients without influenza with mild or moderate asthma.
For example, in one phase 1 clinical trial (the first step in drug development) at the University of Ohio, researchers reported that consuming the fruit could reduce the markers of DNA damage in oral cancer survivors.
Using our automated pipeline in combination with AgilePindelFilter, we successfully identified all 24 insertion/deletion variants that had been previously reported in the phase one cohort (see Table 1).
Moreover, despite the lack of effectiveness in term of response rate, the observed median overall survival is similar to the one reported in the MRC phase III randomised trial, comparing IFN α (8.5 months) to medroxyprogesterone acetate, with obviously a toxicity profile that would favour IM862 (MRC Renal Cancer Collaborators, 1999).
Nevertheless, our mean HOMA-IR values are comparable or even somewhat lower than the ones reported in the chronic phase after stroke, which argues against a substantial influence of acute phase reaction in our results (23).
39– 41 Thirty malignancies were reported in 26 patients treated with ustekinumab over 100 weeks in the PHOENIX 2 trial, two of which were solid tumors and the remaining 28 were cutaneous, with no malignancies reported in PHOENIX 1. 37, 38 One cutaneous malignancy was reported in the Phase II trial in the placebo group and two in the treatment groups, as well as a case of prostate cancer.
16 One case of systemic lupus erythematosus (SLE) was reported in Phase III clinical trials.
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