[c09aa8]: / clusters / 9knumclustersv2 / clust_360.txt

Download this file

40 lines (39 with data), 29.6 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject\r\nNOTE: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Negative serum pregnancy test done ? days prior to registration, for women of childbearing potential only
Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through days after the last dose of study drug OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through months after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Non-pregnant and non-lactating\r\n* Female patients who:\r\n** Are postmenopausal for at least year before the screening visit, OR\r\n** Are surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice effective methods of contraception, at the same time, from the time of signing the informed consent form through days after the last dose of study drug, AND\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: if they are of childbearing potential, agree to one of the following:\r\n** Practice effective methods of contraception, at the same time, from the time of signing the informed consent form through days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Willing to follow strict birth control measures;\r\n* Female patients: If they are of childbearing potential, agree to one of the following:\r\n** Practice effective methods of contraception, at the same time, from the time of signing the informed consent form through days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Persons able to father a child: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who: are postmenopausal for at least year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice effective methods of contraception, at the same time, from the time of signing the informed consent through days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception; MUST have a negative serum or urine pregnancy test within days of initiating protocol treatment unless prior hysterectomy or menopause (defined as consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; should a woman become pregnant or suspect she is pregnant, she should inform her treatment physician immediately; male patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g. calendar, ovulation, symptothermal, post ovulation methods for the female partner] and withdrawal are not acceptable methods of contraception, or agree not to donate sperm during the course of this study or days after receiving their last dose of study drug
Willing to follow strict birth control measures\r\n* Female patients: if they are of childbearing potential, agree to one of the following:\r\n** Practice effective methods of contraception, at the same time, from the time of signing the informed consent form through days after the last dose of study drug, AND must also adhere to the guidelines of any treatment specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR \r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception)\r\n* Agree not to donate sperm during the course of this study or days after receiving their last dose of study drug
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Patients who: a) are postmenopausal for at least year before the screening visit, OR; b) are surgically sterile, OR; c) if they are of childbearing potential, agree to practice effective methods of contraception, at the same time, from the time of signing the informed consent form through days after the last dose of study drug, OR; d) agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: e) agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR; f) agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Willing to follow strict birth control measures as suggested below\r\n* Female patients: if they are of childbearing potential (except if postmenopausal for at least year before the screening visit, OR are surgically sterile), agree to one of the following:\r\n** Practice effective methods of contraception, at the same time, from the time of signing the informed consent form through days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: If they are of childbearing potential, must agree to one of the following:\r\n** Practice effective methods of contraception, at the same time, from the time of signing the informed consent form through days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception)
Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: If they are of childbearing potential, must agree to one of the following:\r\n** Practice effective methods of contraception, at the same time, from the time of signing the informed consent form through days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post vasectomy), have to either: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through months after the last dose of study treatment, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through days after the last dose of lenalidomide (Revlimid) or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Men who are sexually active with women who are of childbearing potential must adhere to contraception for a period of half-lives plus days for a total of months after their last dose of nivolumab
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, or\r\n* Agree to completely abstain from heterosexual intercourse; periodic abstinence (calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception\r\n* Agree not to donate sperm during the course of this study or days after receiving their last dose of study drug
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice two effective contraception measures during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following: agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study treatment, OR \r\n* Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who: are postmenopausal for at least year, OR are surgically sterile, OR if they are of childbearing potential, agree to practice effective methods of contraception, from the time of signing the informed consent through days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception;) male patients, even if surgically sterilized, must agree to one of the following: agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e. status post-vasectomy) must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)