1982;5(6):649 -55. GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre -disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5 Dead OSE2101 Protocol OSE2101C301 Confidential Version n°6.0 Page 100 of 101 02 February 2022 APPENDIX 4: GUIDANCE ON CONTRACEPTION ACCEPTABLE METHODS FOR PROTOCOLS WITH A TERATOGENIC DRUG OR WHEN THERE IS INSUFFICIENT INFORMATION TO DETERMINE TERATOGENICITY (CHOOSE ONE OF THE FOLLOWING 3 OPTIONS)a OPTION 1: Any TWO of the following methods ➢ Hormonal methods of contraception b, c, d ➢ IUD c, d, e ➢ Vasectomy d, f ➢ Tubal Ligationd ➢ A Barrier method (Female or Male Condom with spermicide, Cervical Cap with spermicide,Diaphragm with spermicide) OPTION 2: Male condom (with spermicide) and diaphragmg OPTION 3: Male condom (with spermicide) and cervical capg a The theoretical failure rate for any of the options listed is considerably less than 1% per year b Excludes progestin -only pills d A highly effective method of birth control with a fa ilure rate less than 1% per year e IUDS used should have a failure rate less than 1% (highly effective method), such as Mirena and ParaGard f Must be at least 90 days from date of surgery with a semen analysis documenting azoospermia g These 2 barrier meth ods together are acceptable for a teratogenic drug UNACCEPTABLE METHODS OF CONTRACEPTION Abstinence (including periodic abstinence) No method Withdrawal Rhythm Vaginal Sponge Any barrier method without spermicide Spermicide Progestin only pills Concomitant use of female and male condom In countries where spermicide is not available or its use is not considered compatible with male condoms, use of a male condom without spermicide in conjunction with a hormonal method, IUD, or tubal ligation will b e acceptable to fulfill this recommendation. Any barrier method when used alone (without spermicide) or the concomitant use of a female and male condom, is not considered a sufficient method of contraception, as each carries a failure rate of > 1%. Women o f childbearing potential (WOCBP) receiving OSE2101 will be instructed to adhere to contraception for a period of 90 days after the last dose of investigational product. Men receiving OSE2101 Protocol OSE2101C301 Confidential Version n°6.0 Page 101 of 101 02 February 2022 OSE2101 and who are sexually active with WOCBP will be instructed to adhe re to contraception for a period of 90 days after the last dose of investigational product. For women of childbearing potential (WOCBP) randomized to receive docetaxel, they will be instructed to adhere to contraception for a period of 33 days after the last dose of investigational product. Men randomized to receive docetaxel must follow instructions for birth control as per the SmPC (6 months after discontinuation of treatment), or package insert. Women of childbearing potential should be advised to use effective contraceptive measures to prevent pregnancy during the treatment with pemetrexed