NTP Study C06111 Pathology Tables
STATISTICAL ANALYSIS OF SURVIVAL DATA BENZYL ALCOHOL BY GAVAGE CONTRACT NUMBER: 600262 CHEMICAL NUMBER(S): C06111 SPECIES: RATS MICE KAPLAN-MEIER ANALYSIS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 1 DOSE= ( 0.0) VEHICLE MEDIAN BIRTH DATE: 01/30/81 600262 RG 14VM MALE RATS C06111 START OF STUDY: 03/30/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 4:C95 59:C63 70:C89 76:C60 86:C78 89:C65 89:C84 91:C67 93:C68 94:C58 94:C96 95:C73 95:C97 96:C53 98:C87 99:C57 101:C82 102:C51 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 11:100 60:C59 81:C69 85:C81 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C52 104:C54 104:C55 104:C56 104:C61 104:C62 104:C64 104:C66 104:C70 104:C71 104:C72 104:C74 104:C75 104:C76 104:C77 104:C79 104:C80 104:C83 104:C85 104:C86 104:C88 104:C90 104:C91 104:C92 104:C93 104:C94 104:C98 104:C99 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 18 ACCIDENTAL DEATH OR MISSING: 4 SCHEDULED OR TERMINAL SACRIFICE: 28 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 2 DOSE= ( 40000.0) LOW DOSE MEDIAN BIRTH DATE: 01/30/81 600262 RG 14LM MALE RATS C06111 START OF STUDY: 03/30/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 15:C78 24:C95 79:C88 89:C59 89:C72 91:C83 97:C94 98:C68 99:C76 100:100 100:C84 101:C80 102:C60 102:C89 103:C92 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 16:C97 21:C57 40:C56 41:C66 41:C79 42:C71 49:C93 55:C77 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C51 104:C52 104:C53 104:C54 104:C55 104:C58 104:C61 104:C62 104:C63 104:C64 104:C65 104:C67 104:C69 104:C70 104:C73 104:C74 104:C75 104:C81 104:C82 104:C85 104:C86 104:C87 104:C90 104:C91 104:C96 104:C98 104:C99 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 15 ACCIDENTAL DEATH OR MISSING: 8 SCHEDULED OR TERMINAL SACRIFICE: 27 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 3 DOSE= ( 80000.0) HIGH DOSE MEDIAN BIRTH DATE: 01/30/81 600262 RG 14HM MALE RATS C06111 START OF STUDY: 03/30/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 55:C89 65:C99 75:C91 78:C83 80:C72 89:C66 92:C96 93:C69 95:C61 96:C51 100:C58 103:C64 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 0:C81 1:C52 9:C54 9:C62 48:C68 48:C78 48:C90 49:C55 57:C93 85:C59 95:C79 97:C98 98:C71 98:C87 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:100 104:C53 104:C56 104:C57 104:C60 104:C63 104:C65 104:C67 104:C70 104:C73 104:C74 104:C75 104:C76 104:C77 104:C80 104:C82 104:C84 104:C85 104:C86 104:C88 104:C92 104:C94 104:C95 104:C97 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 12 ACCIDENTAL DEATH OR MISSING: 14 SCHEDULED OR TERMINAL SACRIFICE: 24 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 1 600262 RG 14VM MALE RATS C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 4 0.980 0.020 4 0.980 0.020 49 59 0.960 0.028 59 0.940 0.034 47 70 0.939 0.034 70 0.900 0.042 45 76 0.918 0.039 76 0.880 0.046 44 86 0.896 0.044 86 0.820 0.054 41 89 0.852 0.052 89 0.780 0.059 39 91 0.830 0.055 91 0.760 0.060 38 93 0.809 0.058 93 0.740 0.062 37 94 0.765 0.062 94 0.700 0.065 35 95 0.721 0.066 95 0.660 0.067 33 96 0.699 0.067 96 0.640 0.068 32 98 0.677 0.069 98 0.620 0.069 31 99 0.656 0.070 99 0.600 0.069 30 101 0.634 0.071 101 0.580 0.070 29 102 0.612 0.072 102 0.560 0.070 28 104 0.560 0.070 28 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 2 600262 RG 14LM MALE RATS C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 15 0.980 0.020 15 0.980 0.020 49 24 0.959 0.028 24 0.920 0.038 46 79 0.935 0.036 79 0.780 0.059 39 89 0.887 0.048 89 0.740 0.062 37 91 0.863 0.052 91 0.720 0.063 36 97 0.839 0.056 97 0.700 0.065 35 98 0.815 0.059 98 0.680 0.066 34 99 0.791 0.062 99 0.660 0.067 33 100 0.743 0.067 100 0.620 0.069 31 101 0.719 0.069 101 0.600 0.069 30 102 0.671 0.072 102 0.560 0.070 28 103 0.647 0.074 103 0.540 0.070 27 104 0.540 0.070 27 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 3 600262 RG 14HM MALE RATS C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 55 0.976 0.024 55 0.820 0.054 41 65 0.952 0.033 65 0.780 0.059 39 75 0.927 0.040 75 0.760 0.060 38 78 0.903 0.046 78 0.740 0.062 37 80 0.879 0.051 80 0.720 0.063 36 89 0.853 0.055 89 0.680 0.066 34 92 0.828 0.059 92 0.660 0.067 33 93 0.803 0.062 93 0.640 0.068 32 95 0.778 0.065 95 0.620 0.069 31 96 0.752 0.068 96 0.580 0.070 29 100 0.723 0.071 100 0.500 0.071 25 103 0.694 0.074 103 0.480 0.071 24 104 0.480 0.071 24 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 GRAPH 1 600262 MALE RATS C06111 RUN DATE 02/08/96 0 15 30 45 60 75 90 105 120 135 150 + + + + + + + + + + + ----------------------------------------------------------------------------------------------------- 1.0+***********333333333333333333333333333 + 1111111*******11111111111111111111***3333 + 22222222222222222222222************222 + 111*1 2222222 + 3**11111 2 .9+ 33 11* P + 333333*22 R + ***2222 O + *1 2 B + 3* 22 A .8+ ** 22 B + *3 2 I + 1333* L + 1 * I + 11 **3 T .7+ 11 23 Y + 11 22 + 11 2 O + 112 F + 11 .6+ S + U + R + V + I .5+ V + A + L + + .4+ + + + + K .3+ A + P + L + A + N .2+ + M + E + I + E .1+ R + + + + .0+ ----------------------------------------------------------------------------------------------------- + + + + + + + + + + + 0 15 30 45 60 75 90 105 120 135 150 WEEKS ON STUDY VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 600262 MALE RATS C06111 STATISTICAL ANALYSIS OF SURVIVAL DATA MEAN SURVIVAL STANDARD STANDARD GROUP ANIMALS IN WEEKS DEVIATION ERROR 1 50 93.7 21.04 2.976 2 50 88.1 28.16 3.982 3 50 85.2 29.85 4.222 LIFE TABLE ANALYSIS GROUP CHI-SQUARE P-VALUE 1 VS. 2 0.1219 0.7270 1 VS. 3 0.2921 0.5889 2 VS. 3 0.0038 0.9506 TREND 0.4214 0.5162 VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 1 DOSE= ( 0.0) VEHICLE MEDIAN BIRTH DATE: 01/30/81 600262 RG 14VF FEMALE RATS C06111 START OF STUDY: 03/30/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 76:C90 82:C60 86:C64 89:C87 91:C63 96:C68 99:C52 99:C93 99:C98 101:C81 102:C97 103:C59 103:C61 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 95:C86 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:100 104:C51 104:C53 104:C54 104:C55 104:C56 104:C57 104:C58 104:C62 104:C65 104:C66 104:C67 104:C69 104:C70 104:C71 104:C72 104:C73 104:C74 104:C75 104:C76 104:C77 104:C78 104:C79 104:C80 104:C82 104:C83 104:C84 104:C85 104:C88 104:C89 104:C91 104:C92 104:C94 104:C95 104:C96 104:C99 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 13 ACCIDENTAL DEATH OR MISSING: 1 SCHEDULED OR TERMINAL SACRIFICE: 36 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 2 DOSE= ( 40000.0) LOW DOSE MEDIAN BIRTH DATE: 01/30/81 600262 RG 14LF FEMALE RATS C06111 START OF STUDY: 03/30/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 0:C55 9:C94 16:C63 23:C65 44:C61 68:C64 71:C51 78:100 81:C91 83:C87 88:C99 89:C72 94:C70 99:C67 99:C68 103:C95 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 16:C84 16:C93 23:C56 23:C97 24:C60 40:C69 44:C76 44:C89 49:C54 50:C82 52:C57 53:C62 53:C78 54:C53 56:C59 102:C80 104:C83 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C52 104:C58 104:C66 104:C71 104:C73 104:C74 104:C75 104:C77 104:C79 104:C81 104:C85 104:C86 104:C88 104:C90 104:C92 104:C96 104:C98 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 16 ACCIDENTAL DEATH OR MISSING: 17 SCHEDULED OR TERMINAL SACRIFICE: 17 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 3 DOSE= ( 80000.0) HIGH DOSE MEDIAN BIRTH DATE: 01/30/81 600262 RG 14HF FEMALE RATS C06111 START OF STUDY: 03/30/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 16:C67 23:C56 23:C66 24:C68 28:C60 45:C96 51:C89 59:C77 85:C78 88:C61 93:C86 95:C54 95:C93 97:C72 99:C57 99:C80 100:C62 101:C95 102:C59 102:C84 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 15:C55 17:C97 21:C88 23:C63 41:C64 45:C73 47:C76 48:C85 49:C81 54:100 54:C99 56:C91 103:C79 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C51 104:C52 104:C53 104:C58 104:C65 104:C69 104:C70 104:C71 104:C74 104:C75 104:C82 104:C83 104:C87 104:C90 104:C92 104:C94 104:C98 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 20 ACCIDENTAL DEATH OR MISSING: 13 SCHEDULED OR TERMINAL SACRIFICE: 17 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 1 600262 RG 14VF FEMALE RATS C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 76 0.980 0.020 76 0.980 0.020 49 82 0.960 0.028 82 0.960 0.028 48 86 0.940 0.034 86 0.940 0.034 47 89 0.920 0.038 89 0.920 0.038 46 91 0.900 0.042 91 0.900 0.042 45 96 0.880 0.046 96 0.860 0.049 43 99 0.818 0.055 99 0.800 0.057 40 101 0.798 0.057 101 0.780 0.059 39 102 0.777 0.059 102 0.760 0.060 38 103 0.736 0.063 103 0.720 0.063 36 104 0.720 0.063 36 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 2 600262 RG 14LF FEMALE RATS C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 0 0.980 0.020 0 0.980 0.020 49 9 0.960 0.028 9 0.960 0.028 48 16 0.940 0.034 16 0.940 0.034 47 23 0.919 0.039 23 0.880 0.046 44 44 0.896 0.044 44 0.780 0.059 39 68 0.866 0.052 68 0.580 0.070 29 71 0.836 0.058 71 0.560 0.070 28 78 0.807 0.063 78 0.540 0.070 27 81 0.777 0.067 81 0.520 0.071 26 83 0.747 0.071 83 0.500 0.071 25 88 0.717 0.074 88 0.480 0.071 24 89 0.687 0.077 89 0.460 0.070 23 94 0.657 0.079 94 0.440 0.070 22 99 0.597 0.083 99 0.400 0.069 20 103 0.566 0.084 103 0.360 0.068 18 104 0.315 0.073 16 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 3 600262 RG 14HF FEMALE RATS C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 16 0.980 0.020 16 0.960 0.028 48 23 0.937 0.035 23 0.880 0.046 44 24 0.915 0.041 24 0.840 0.052 42 28 0.893 0.045 28 0.820 0.054 41 45 0.871 0.049 45 0.780 0.059 39 51 0.846 0.054 51 0.680 0.066 34 59 0.819 0.059 59 0.600 0.069 30 85 0.792 0.063 85 0.580 0.070 29 88 0.764 0.066 88 0.560 0.070 28 93 0.737 0.069 93 0.540 0.070 27 95 0.682 0.074 95 0.500 0.071 25 97 0.655 0.076 97 0.480 0.071 24 99 0.601 0.079 99 0.440 0.070 22 100 0.573 0.080 100 0.420 0.070 21 101 0.546 0.081 101 0.400 0.069 20 102 0.491 0.081 102 0.360 0.068 18 104 0.340 0.067 17 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 GRAPH 2 600262 FEMALE RATS C06111 RUN DATE 02/08/96 0 15 30 45 60 75 90 105 120 135 150 + + + + + + + + + + + ----------------------------------------------------------------------------------------------------- 1.0+************1111111111111111111111111111111111111111 +2222222 33333 11111 + 222222 3 111 + 2222*3 111 + 2****2222222222 111 .9+ 3333333333**222222222222222 1111 P + 33333 2 111 R + 3 222 1 O + 333333 222222 1 B + 3333333333333*33333 11 A .8+ 222 333 11 B + 22 3 11 I + 2 3333 1 L + 22222 33 1 I + 2 3 T .7+ 2 3 Y + 2222*33 + 22** O + * F + * .6+ **22 S + 3 2 U + 3 2 R + 33 V + 3 I .5+ 33 V + A + L + + .4+ + + + + K .3+ A + P + L + A + N .2+ + M + E + I + E .1+ R + + + + .0+ ----------------------------------------------------------------------------------------------------- + + + + + + + + + + + 0 15 30 45 60 75 90 105 120 135 150 WEEKS ON STUDY VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 600262 FEMALE RATS C06111 STATISTICAL ANALYSIS OF SURVIVAL DATA MEAN SURVIVAL STANDARD STANDARD GROUP ANIMALS IN WEEKS DEVIATION ERROR 1 50 101.5 6.18 0.874 2 50 72.4 34.25 4.844 3 50 75.5 33.36 4.718 LIFE TABLE ANALYSIS GROUP CHI-SQUARE P-VALUE 1 VS. 2 3.5779 0.0586 1 VS. 3 6.2279 0.0126 2 VS. 3 0.0817 0.7751 TREND 6.2759 0.0122 VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 1 DOSE= ( 0.0) VEHICLE MEDIAN BIRTH DATE: 11/07/80 600262 MA 14VM MALE MICE C06111 START OF STUDY: 01/05/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 21:C40 39:C22 48:C35 54:C08 57:C27 61:C01 67:C03 79:C19 98:C31 99:C47 102:C21 103:C50 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 9:C36 16:C30 53:C09 84:C04 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C02 104:C05 104:C06 104:C07 104:C10 104:C11 104:C12 104:C13 104:C14 104:C15 104:C16 104:C17 104:C18 104:C20 104:C23 104:C24 104:C25 104:C26 104:C28 104:C29 104:C32 104:C33 104:C34 104:C37 104:C38 104:C39 104:C41 104:C42 104:C43 104:C44 104:C45 104:C46 104:C48 104:C49 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 12 ACCIDENTAL DEATH OR MISSING: 4 SCHEDULED OR TERMINAL SACRIFICE: 34 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 2 DOSE= ( 10000.0) LOW DOSE MEDIAN BIRTH DATE: 11/07/80 600262 MA 14LM MALE MICE C06111 START OF STUDY: 01/05/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 66:C21 68:C20 69:C39 75:C38 75:C47 87:C04 92:C13 92:C27 92:C34 95:C14 97:C07 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 26:C03 36:C41 53:C23 71:C40 83:C26 85:C01 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C02 104:C05 104:C06 104:C08 104:C09 104:C10 104:C11 104:C12 104:C15 104:C16 104:C17 104:C18 104:C19 104:C22 104:C24 104:C25 104:C28 104:C29 104:C30 104:C31 104:C32 104:C33 104:C35 104:C36 104:C37 104:C42 104:C43 104:C44 104:C45 104:C46 104:C48 104:C49 104:C50 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 11 ACCIDENTAL DEATH OR MISSING: 6 SCHEDULED OR TERMINAL SACRIFICE: 33 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 3 DOSE= ( 20000.0) HIGH DOSE MEDIAN BIRTH DATE: 11/07/80 600262 MA 14HM MALE MICE C06111 START OF STUDY: 01/05/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 43:C14 56:C24 57:C27 84:C31 85:C49 94:C29 95:C34 97:C41 99:C16 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 7:C04 8:C10 65:C22 79:C05 95:C01 102:C36 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C02 104:C03 104:C06 104:C07 104:C08 104:C09 104:C11 104:C12 104:C13 104:C15 104:C17 104:C18 104:C19 104:C20 104:C21 104:C23 104:C25 104:C26 104:C28 104:C30 104:C32 104:C33 104:C35 104:C37 104:C38 104:C39 104:C40 104:C42 104:C43 104:C44 104:C45 104:C46 104:C47 104:C48 104:C50 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 9 ACCIDENTAL DEATH OR MISSING: 6 SCHEDULED OR TERMINAL SACRIFICE: 35 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 1 600262 MA 14VM MALE MICE C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 21 0.979 0.021 21 0.940 0.034 47 39 0.958 0.029 39 0.920 0.038 46 48 0.938 0.035 48 0.900 0.042 45 54 0.916 0.040 54 0.860 0.049 43 57 0.895 0.044 57 0.840 0.052 42 61 0.874 0.048 61 0.820 0.054 41 67 0.852 0.052 67 0.800 0.057 40 79 0.831 0.055 79 0.780 0.059 39 98 0.809 0.057 98 0.740 0.062 37 99 0.787 0.060 99 0.720 0.063 36 102 0.765 0.062 102 0.700 0.065 35 103 0.743 0.064 103 0.680 0.066 34 104 0.680 0.066 34 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 2 600262 MA 14LM MALE MICE C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 66 0.979 0.021 66 0.920 0.038 46 68 0.957 0.029 68 0.900 0.042 45 69 0.936 0.036 69 0.880 0.046 44 75 0.893 0.045 75 0.820 0.054 41 87 0.870 0.050 87 0.760 0.060 38 92 0.801 0.059 92 0.700 0.065 35 95 0.778 0.062 95 0.680 0.066 34 97 0.755 0.064 97 0.660 0.067 33 104 0.660 0.067 33 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 3 600262 MA 14HM MALE MICE C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 43 0.979 0.021 43 0.940 0.034 47 56 0.958 0.029 56 0.920 0.038 46 57 0.938 0.035 57 0.900 0.042 45 84 0.916 0.040 84 0.840 0.052 42 85 0.894 0.045 85 0.820 0.054 41 94 0.872 0.049 94 0.800 0.057 40 95 0.850 0.052 95 0.780 0.059 39 97 0.828 0.055 97 0.740 0.062 37 99 0.806 0.058 99 0.720 0.063 36 104 0.700 0.065 35 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 GRAPH 3 600262 MALE MICE C06111 RUN DATE 02/08/96 0 15 30 45 60 75 90 105 120 135 150 + + + + + + + + + + + ----------------------------------------------------------------------------------------------------- 1.0+******************************222222222222222 + 1111111111111 333333333 22 + 1111111 33 22 + 11111 33333333*****333333 + 111 2 33 .9+ 1111 2222222**33333 P + 11111 2 3 R + 111111111 2222 333 O + 11111111*111* B + 2 *3 A .8+ 222 1*333 B + 222111 I + 222** L + 1 I + T .7+ Y + + O + F + .6+ S + U + R + V + I .5+ V + A + L + + .4+ + + + + K .3+ A + P + L + A + N .2+ + M + E + I + E .1+ R + + + + .0+ ----------------------------------------------------------------------------------------------------- + + + + + + + + + + + 0 15 30 45 60 75 90 105 120 135 150 WEEKS ON STUDY VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 600262 MALE MICE C06111 STATISTICAL ANALYSIS OF SURVIVAL DATA MEAN SURVIVAL STANDARD STANDARD GROUP ANIMALS IN WEEKS DEVIATION ERROR 1 50 90.6 26.15 3.698 2 50 94.0 18.41 2.604 3 50 94.2 22.69 3.209 LIFE TABLE ANALYSIS GROUP CHI-SQUARE P-VALUE 1 VS. 2 0.0025 0.9599 1 VS. 3 0.2877 0.5917 2 VS. 3 0.1175 0.7317 TREND 0.4416 0.5063 VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 1 DOSE= ( 0.0) VEHICLE MEDIAN BIRTH DATE: 11/07/80 600262 MA 14VF FEMALE MICE C06111 START OF STUDY: 01/05/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 19:C20 22:C03 40:C23 65:C16 66:C18 71:C08 71:C27 71:C37 71:C39 75:C46 77:C49 77:C50 83:C11 83:C24 85:C40 90:C38 91:C32 95:C36 96:C10 103:C26 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 3:C14 4:C04 5:C06 103:C17 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C01 104:C02 104:C05 104:C07 104:C09 104:C12 104:C13 104:C15 104:C19 104:C21 104:C22 104:C25 104:C28 104:C29 104:C30 104:C31 104:C33 104:C34 104:C35 104:C41 104:C42 104:C43 104:C44 104:C45 104:C47 104:C48 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 20 ACCIDENTAL DEATH OR MISSING: 4 SCHEDULED OR TERMINAL SACRIFICE: 26 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 2 DOSE= ( 10000.0) LOW DOSE MEDIAN BIRTH DATE: 11/07/80 600262 MA 14LF FEMALE MICE C06111 START OF STUDY: 01/05/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 3:C06 4:C40 45:C37 61:C39 63:C38 71:C13 74:C47 76:C43 77:C50 81:C32 82:C11 85:C16 90:C14 91:C18 92:C17 96:C04 100:C27 104:C48* ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 70:C05 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C01 104:C02 104:C03 104:C07 104:C08 104:C09 104:C10 104:C12 104:C15 104:C19 104:C20 104:C21 104:C22 104:C23 104:C24 104:C25 104:C26 104:C28 104:C29 104:C30 104:C31 104:C33 104:C34 104:C35 104:C36 104:C41 104:C42 104:C44 104:C45 104:C46 104:C49 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 18 ACCIDENTAL DEATH OR MISSING: 1 SCHEDULED OR TERMINAL SACRIFICE: 31 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES *NOTE: ANIMAL DIED PRIOR TO THE TSAC PERIOD VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 3 DOSE= ( 20000.0) HIGH DOSE MEDIAN BIRTH DATE: 11/07/80 600262 MA 14HF FEMALE MICE C06111 START OF STUDY: 01/05/81 NATURAL DEATH OR MORIBUND SACRIFICE (WEEKS:ANIMAL NUMBER) 79:C26 91:C15 92:C22 92:C44 93:C24 95:C28 102:C09 102:C48 103:C42 ACCIDENTAL DEATH OR MISSING (WEEKS:ANIMAL NUMBER) 3:C10 3:C17 8:C05 21:C04 97:C41 SCHEDULED OR TERMINAL SACRIFICE (WEEKS:ANIMAL NUMBER) 104:C01 104:C02 104:C03 104:C06 104:C07 104:C08 104:C11 104:C12 104:C13 104:C14 104:C16 104:C18 104:C19 104:C20 104:C21 104:C23 104:C25 104:C27 104:C29 104:C30 104:C31 104:C32 104:C33 104:C34 104:C35 104:C36 104:C37 104:C38 104:C39 104:C40 104:C43 104:C45 104:C46 104:C47 104:C49 104:C50 DISPOSITION ANIMALS NATURAL DEATH OR MORIBUND SACRIFICE: 9 ACCIDENTAL DEATH OR MISSING: 5 SCHEDULED OR TERMINAL SACRIFICE: 36 TOTAL: 50 NOTE: ANIMALS THAT DIED NATURALLY OR WERE MORIBUND SACRIFICES AFTER THE START OF THE TERMINAL SACRIFICE PERIOD ARE CLASSIFIED AS TERMINAL SACRIFICES VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 1 600262 MA 14VF FEMALE MICE C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 19 0.979 0.021 19 0.920 0.038 46 22 0.957 0.029 22 0.900 0.042 45 40 0.936 0.036 40 0.880 0.046 44 65 0.915 0.041 65 0.860 0.049 43 66 0.894 0.045 66 0.840 0.052 42 71 0.809 0.057 71 0.760 0.060 38 75 0.787 0.060 75 0.740 0.062 37 77 0.745 0.064 77 0.700 0.065 35 83 0.702 0.067 83 0.660 0.067 33 85 0.681 0.068 85 0.640 0.068 32 90 0.660 0.069 90 0.620 0.069 31 91 0.638 0.070 91 0.600 0.069 30 95 0.617 0.071 95 0.580 0.070 29 96 0.596 0.072 96 0.560 0.070 28 103 0.574 0.072 103 0.540 0.070 27 104 0.520 0.071 26 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 2 600262 MA 14LF FEMALE MICE C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 3 0.980 0.020 3 0.980 0.020 49 4 0.960 0.028 4 0.960 0.028 48 45 0.940 0.034 45 0.940 0.034 47 61 0.920 0.038 61 0.920 0.038 46 63 0.900 0.042 63 0.900 0.042 45 71 0.880 0.046 71 0.860 0.049 43 74 0.859 0.049 74 0.840 0.052 42 76 0.839 0.052 76 0.820 0.054 41 77 0.818 0.055 77 0.800 0.057 40 81 0.798 0.057 81 0.780 0.059 39 82 0.777 0.059 82 0.760 0.060 38 85 0.757 0.061 85 0.740 0.062 37 90 0.736 0.063 90 0.720 0.063 36 91 0.716 0.064 91 0.700 0.065 35 92 0.695 0.066 92 0.680 0.066 34 96 0.675 0.067 96 0.660 0.067 33 100 0.655 0.068 100 0.640 0.068 32 104 0.634 0.069 104 0.620 0.069 31 104 0.620 0.069 31 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 GROUP 3 600262 MA 14HF FEMALE MICE C06111 * KAPLAN-MEIER SURVIVAL CURVE STANDARD SURVIVAL CURVE ( P(T) = ADJUSTED PROPORTION OF SURVIVORS ) (INCLUDES ALL OBS. < END OF STUDY = 104) ( S(T) = OBSERVED PROPORTION OF SURVIVORS ) WEEK P(T) STANDARD WEEK S(T) STANDARD NUMBER ERROR OF P(T) ERROR OF S(T) SURVIVING 79 0.978 0.022 79 0.900 0.042 45 91 0.957 0.030 91 0.880 0.046 44 92 0.913 0.042 92 0.840 0.052 42 93 0.891 0.046 93 0.820 0.054 41 95 0.870 0.050 95 0.800 0.057 40 102 0.825 0.056 102 0.740 0.062 37 103 0.803 0.059 103 0.720 0.063 36 104 0.720 0.063 36 FINAL SURVIVORSHIP * THE KAPLAN-MEIER SURVIVAL CURVE ADJUSTS FOR ACCIDENTAL DEATH AND MISSING ANIMALS VERSION DATE 10/28/88 GRAPH 4 600262 FEMALE MICE C06111 RUN DATE 02/08/96 0 15 30 45 60 75 90 105 120 135 150 + + + + + + + + + + + ----------------------------------------------------------------------------------------------------- 1.0+**************3333333333333333333333333333333333333333 + 22 111 333333333 + 222222222222*************222 3 + 111************11 3 + 2211 33 .9+ 22**** 33 P + *22 3 R + 1 222 333333 O + 1 2 3 B + 1 2222 33 A .8+ 1111 22 3 B + 11 222 I + 1 2222 L + 11111 22 I + 1 2 T .7+ 111 2222 Y + 1111 2222 + 11 222 O + 111 2 F + 11 .6+ 111111 S + 1 U + R + V + I .5+ V + A + L + + .4+ + + + + K .3+ A + P + L + A + N .2+ + M + E + I + E .1+ R + + + + .0+ ----------------------------------------------------------------------------------------------------- + + + + + + + + + + + 0 15 30 45 60 75 90 105 120 135 150 WEEKS ON STUDY VERSION DATE 10/28/88 KAPLAN-MEIER ANALYSIS RUN DATE 02/08/96 600262 FEMALE MICE C06111 STATISTICAL ANALYSIS OF SURVIVAL DATA MEAN SURVIVAL STANDARD STANDARD GROUP ANIMALS IN WEEKS DEVIATION ERROR 1 50 85.6 29.41 4.159 2 50 92.0 23.38 3.306 3 50 94.7 26.11 3.693 LIFE TABLE ANALYSIS GROUP CHI-SQUARE P-VALUE 1 VS. 2 0.2140 0.6437 1 VS. 3 6.2335 0.0125 2 VS. 3 3.5621 0.0591 TREND 6.2955 0.0121 --multipart-boundary Content-type: text/plain Range: bytes 77794-77794/77794 --multipart-boundary--