[c09aa8]: / templates / fillins / 575.txtFILLINS.csv

Download this file

# Blank 1 Frequency Blank 2 Frequency
1 1 65 or breastfeeding 26
2 2 women of child bearing potential who are 42 or nursing lactating women 20
3 20 women who are 4 women 14
4 18 female of child bearing potential who is or has intention to be 1 women or nursing mothers 6
5 24 just prior to first vaccination within 21 days r n women of child bearing potential who are 1 5
6 38 is a woman of child bearing potential wocbp who are 1 or breast feeding 5
7 39 women of child bearing potential must attest to not being 1 or nursing lactating women . 5
8 44 all women of child bearing potential wocbp shomcLd be instructed to contact the investigator immediately if they suspect they might be 1 or breastfeeding females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential 2
9 47 they must not be 1 or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant 2
10 53 patients who are 1 women or nursing mothers are not eligible for this trial patients of child bearing potential must use adequate contraception 2
11 56 patients that become 1 or nursing mothers 2
12 64 donor must not be 1 or nursing lactating 2
13 69 lactation or 1 or breast feeding women will not be entered on this study women of childbearing potential must obtain a pregnancy test child bearing potential is defined as having neither of the following r n > = 12 months of non therapy induced amenorrhea r n surgically sterile absence of ovaries and / or uterus 1
14 70 not be 1 or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant . 1
15 79 study drug must not be administered to 1 or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant . females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential 1
16 119 lactating / nursing or plan to become 1 or breast feeding patients or any patient with child bearing potential not using adequate contraception 1
17 3 NA or breastfeeding women of child bearing potential are defined as all women except women who are post menopausal or who have had a hysterectomy postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year 1
18 4 NA or lactating woman as evaluated by serum testing within 48 hours of administration of the first vaccine in women of child bearing potential 1
19 5 NA or breastfeeding . 1
20 6 NA or breastfeeding women with a positive pregnancy test at enrollment or prior to administration of vaccine 1
21 7 NA or breastfeeding r n women with a positive pregnancy test prior to administration of vaccine 1
22 8 NA or nursing 1
23 9 NA pregnancy testing will be at the discretion of the treating physician 1
24 10 NA or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant . females who have undergone surgical sterilization are not considered to be of childbearing potential 1
25 11 NA or breast feeding women women with child bearing potential must use effective measures to prevent pregnancy while receiving pegylated liposomal doxorubicin 1
26 12 NA or breast feeding . 1
27 13 NA or breastfeeding additionally 1
28 14 NA while on study protocol will be discontinued immediately 1
29 15 NA or breastfeeding . recipient exclusion criteria 1
30 16 NA women and women of child bearing potential are eligible for participation in this study 1
31 17 NA women of child bearing potential will be excluded 1
32 19 NA or become pregnant during the study if the participant is a woman of child bearing potential i . e . 1
33 21 NA and nursing mothers are excluded from this study . 1
34 22 NA or nursing mothers are excluded 1
35 23 NA women are excluded from this study nursing mothers shomcLd stop breastfeeding to be eligible 1
36 25 NA women are excluded from this study in nursing mothers 1
37 26 NA women and breastfeeding mothers are excluded 1
38 27 NA and nursing mothers are excluded from this study 1
39 28 NA women and nursing mothers 1
40 29 NA women are excluded from this study breastfeeding shomcLd be discontinued by nursing mothers who agree to participate in the study 1
41 30 NA women / lactating mothers 1
42 31 NA women or nursing mothers are not eligible for this trial . patients of child bearing potential must use adequate contraception contraceptive pill 1
43 32 NA or nursing lactating women additional exclusion criteria for lxh254 in combination with pdr001 1
44 33 NA or nursing lactating women breastfeeding shomcLd be discontinued 1
45 34 NA or nursing lactating . 1