Childbearing potential, including any female who has had a negative serum pregnancy test within  weeks prior to the first dose of study treatment and for  months after the completion of treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: \r\n* Complete abstinence from sexual intercourse for  days before exposure to investigational product, through the dosing period, and for at least  days after the last dose of investigational product \r\n* Oral contraceptive, either combined or progestogen alone \r\n* Injectable progestogen \r\n* Implants of levonorgestrel\r\n* Estrogenic vaginal ring  \r\n* Percutaneous contraceptive patches \r\n* Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than % per year\r\n* Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n* Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
Childbearing potential includes any female who has had a negative serum pregnancy test within  days of study registration, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n* Complete abstinence from sexual intercourse for  days before starting treatment, through the treatment, and for at least  month after the last dose of temozolomide\r\n* Oral contraceptive, either combined or progestogen alone. A second barrier method is required during the first month of treatment with oral contraceptives\r\n* Injectable progesterone\r\n* Implants of levonorgestrel\r\n* Estrogenic vaginal ring\r\n* Percutaneous contraceptive patches\r\n* Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than % per year\r\n* Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n* Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). Female participants who are lactating should discontinue nursing prior to the first dose of temozolomide and should refrain from nursing throughout the treatment period and for  days following the last dose of lomustine.
Childbearing potential, including any female who has had a negative serum pregnancy test within  days prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; defined as follows:\r\n* Complete abstinence from sexual intercourse for  days before exposure to investigational product, through the dosing period, and for at least  days after the last dose of investigational product\r\n* Oral contraceptive, either combined or progesterone alone\r\n* Injectable progesterone\r\n* Implants of levonorgestrel\r\n* Estrogenic vaginal ring\r\n* Percutaneous contraceptive patches\r\n* Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than % per year\r\n* Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n* Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within  weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; GlaxoSmithKline (GSK) acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for  days before exposure to investigational product, through the dosing period, and for at least  days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Estrogenic vaginal ring\r\n** Percutaneous contraceptive patches\r\n** Intrauterine device (IUD) or intrauterine system (ISU) with a documented failure rate of less than % per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subjects entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal:\r\n*** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >=  year and be greater than  years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >  mIU/mL and an estradiol value <  pg/mL (<  pmol/L)\r\n*** Subjects using HRT must have experienced total cessation of menses for >=  year and be greater than  years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within  weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; Novartis acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for  days before exposure to investigational product, through the dosing period, and for at least  days after the last dose of investigational product; oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring\r\n** Percutaneous contraceptive patches\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than % per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)\r\n* Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for  days following the last dose of study drug
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: \r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation \r\n** Is post-menopausal\r\n*** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >=  year and be greater than  years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >  mIU/mL and an estradiol value <  pg/mL (<  pmol/L)\r\n*** Subjects using HRT must have experienced total cessation of menses for >=  year and be greater than  years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within  days of registration, and agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:\r\n** Complete abstinence from sexual intercourse for  days before exposure to investigational product, through the dosing period, and for at least  days after the last dose of investigational product\r\n** Oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring \r\n** Percutaneous contraceptive patches \r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than % per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal\r\n** Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >=  year and be greater than  years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >  mIU/mL and an estradiol value <  pg/mL (<  pmol/L); subjects using HRT must have experienced total cessation of menses for >=  year and be greater than  years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has had a negative serum pregnancy test within  weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception; Novartis Pharmaceuticals acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:\r\n** Complete abstinence from sexual intercourse for  days before exposure to investigational product, through the dosing period, and for at least  days after the last dose of investigational product \r\n** Oral contraceptive, either combined or progestogen alone\r\n** Injectable progestogen\r\n** Estrogenic vaginal ring\r\n** Percutaneous contraceptive patches\r\n** Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than % per year\r\n** Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for  days following the last dose of study drug
A female is eligible to enter and participate in this study if she is of: non-childbearing potential including \r\n* Any female who has had a surgical procedure rendering her incapable of becoming pregnant\r\n* Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >=  year and be greater than  years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >  mIU/mL and an estradiol value <  pg/mL (<  pmol/L)\r\n* Subjects using HRT must have experienced total cessation of menses for >=  year and be greater than  years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT; childbearing potential, including any female who has had a negative serum pregnancy test within  weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception GlaxoSmithKline (GSK) acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: \r\n** Complete abstinence from sexual intercourse for  days before exposure to investigational product, through the dosing period, and for at least  days after the last dose of investigational product\r\n** Oral contraceptive \r\n** Injectable progestogen\r\n** Implants of levonorgestrel\r\n** Estrogenic vaginal ring \r\n** Percutaneous contraceptive patches \r\n** Intrauterine device (IUD) \r\n** Male partner sterilization\r\n** Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository); female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for  days following the last dose of study drug
Lactating women, women with a positive pregnancy test at Visit  or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilisation if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap plus spermicidal agent).
Men with partners of childbearing potential and women of childbearing potential who are not willing to use adequate contraception from study entry through one year following last treatment dose. (Adequate contraception is defined as abstinence, oral hormonal birth control, hormonal birth control injections, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is the sole partner for a female subject. The double barrier method can be used in regions where considered acceptable and adequate, defined as condom or occlusive cap plus spermicidal agent).