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#2- Date: 19-Dec-03




                                         MEAL SCHEDULE
                WAS THE    MEAL                                                                START TIME                            WAS THE   MEAL
  MEAL          ADMINISTERED?
                                               DATE        OF MEAL                                                                    COMPLETED?
                                                                                               STOP TIME                              (MARK   ONE)
                  (MARK   ONE)
                                                                                                       24   HR. CLOCK




                                                                                                   H     H     M M
            0       NO 1         YES                                                                   24 HR. CLOCK
                                                                                                                                 0     NO 1          YES
                                          D    D       M       M       M       Y       Y

                                                                                                   H    H          M    M




                                         MEAL SCHEDULE
                        WAS THE    MEAL                                                                 START TIME                   WAS THE    MEAL
 MEAL      RELATIVE     ADMINISTERED?                      DATE            OF MEAL                                                    COMPLETED?
             TIME                                                                                       STOP TIME
                          (MARK   ONE)                                                                                                (MARK    ONE)

                                                                                                            24   HR. CLOCK




HIGH-FAT     AM     0      NO 1          YES       D       D       M       M       M       Y   Y        H      H     M M         0      NO 1          YES
                                                                                                             24 HR. CLOCK


                                                                                                        H      H        M    M
STUDY MEDICATION
WAS A NEW     STUDY MEDICATION KIT DISPENSED?                0       NO   1      YES

      KIT NUMBER        DISPENSED AT THIS VISIT:

DATE AND TIME      OF DOSE TAKEN AT THIS VISIT:

              DATE                                    TIME                      NUMBER TAKEN   PER BOTTLE




                                                                                                              SMEDDISP006
                                                24   HR. CLOCK                BOTTLE A             BOTTLE B

  D   D   M    M    M    Y   Y              H    H       M       M
OTHER TREATMENT
IS THE   SUBJECT IN DOSE GROUP   2?    0       NO     1   YES       IF YES,   COMPLETE BELOW

    TREATMENT             WAS    DOSE ADMINISTERED?             DATE    OF    DOSE        TIME     OF   DOSE
                                                                                              24   HR. CLOCK


RITONAVIR 200 mg          0       NO       1        YES
                                                            D   D   M   M     M   Y   Y   H    H        M      M
DOSING - DAY 1

    START DATE     OF INFUSION          START TIME      OF INFUSION         STOP DATE    OF INFUSION      STOP TIME     OF INFUSION
                                                  24   HR. CLOCK                                                  24   HR. CLOCK




     D     D   M   M   M       Y    Y         H    H        M      M        D   D    M   M    M   Y   Y       H    H       M       M

D                                               WEIGHT OF
A
    TOTAL DOSE     DELIVERED                INFUSATE DELIVERED
Y

1                              mg                                      g

    SITE   OF INFUSION:
                       1            LEFT ARM                    2          RIGHT ARM
                       3            CENTRAL LINE             98        OTHER (SPECIFY)



                                                  DOSING CHANGES
                                                                                     S
                                                                           NO

                                                                                    YE
                                                                                             REASON               SPECIFY
                                                                            0        1
     WAS    DOSE OMITTED?
D
A
Y    WAS THE INFUSION TEMPORARILY INTERRUPTED?
      INTERRUPTION DURATION:
1

                           1        MIN       2           HR




                                        DOSE OMITTED REASONS
                                         9 = DELAYED HEMATOLOGIC RECOVERY
                                        12 = DELAYED NON-HEMATOLOGIC RECOVERY (SPECIFY)
                                        98 = OTHER (SPECIFY)

                                        INFUSION INTERRUPTED REASONS
                                          8 = HYPERSENSITIVITY REACTION
                                        17 = ADVERSE EVENT (SPECIFY)
                                        98 = OTHER (SPECIFY)
RECORD OF STUDY MEDICATION
WAS THE   DOSE ADMINISTERED?   0   NO       1       YES


          TREATMENT                         DATE    OF   DOSE         TIME      OF   DOSE

                                                                           24   HR. CLOCK
A           B          C
                                        D   D   M   M     M   Y   Y    H     H       M      M
RECORD OF STUDY MEDICATION

    WAS THE   DOSE ADMINISTERED?   0       NO       1       YES


    DOSE GROUP                             DATE     OF DOSE           TIME      OF DOSE
     (MARK ONE)
                                                                          24   HR. CLOCK
1        2         3
4        5         6                   D   D    M   M   M   Y     Y   H    H       M       M
RECORD OF STUDY MEDICATION

          TREATMENT                             DATE   OF DOSE           TIME      OF DOSE



                                                                              24   HR. CLOCK

     BMS-298585 10 mg
                                        D   D     M    M   M    Y    Y    H       H       M       M



                      RECORD OF STUDY MEDICATION

     WAS THE   DOSE ADMINISTERED?   0       NO         1       YES


      TREATMENT                             DATE      OF DOSE             TIME         OF DOSE



                                                                                  24   HR. CLOCK



                                        D   D    M     M   M    Y    Y        H       H       M       M



                      RECORD OF STUDY MEDICATION

WAS THE   DOSE ADMINISTERED?                    DATE   OF DOSE           TIME      OF     DOSE

                                                                                  24   HR. CLOCK
 0        NO    1     YES
                                        D   D    M     M   M   Y     Y        H       H    M       M
DRUG ADMINISTRATION

           WAS THE    DOSE ADMINISTERED?    0        NO       1     YES


                                                                        START TIME               STOP TIME
          TREATMENT              DATE ADMINISTERED?
                                                                        OF INFUSION              OF INFUSION


                                                                            24   HR. CLOCK           24   HR. CLOCK

      A        B
                                D   D   M   M    M   Y    Y             H    H       M       M   H    H       M       M


WAS   FULL INFUSION COMPLETED?      0       NO            1       YES

TOTAL DOSE ADMINISTERED?                                  mg

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Meal And Smed Modules Part Two

  • 1. #2- Date: 19-Dec-03 MEAL SCHEDULE WAS THE MEAL START TIME WAS THE MEAL MEAL ADMINISTERED? DATE OF MEAL COMPLETED? STOP TIME (MARK ONE) (MARK ONE) 24 HR. CLOCK H H M M 0 NO 1 YES 24 HR. CLOCK 0 NO 1 YES D D M M M Y Y H H M M MEAL SCHEDULE WAS THE MEAL START TIME WAS THE MEAL MEAL RELATIVE ADMINISTERED? DATE OF MEAL COMPLETED? TIME STOP TIME (MARK ONE) (MARK ONE) 24 HR. CLOCK HIGH-FAT AM 0 NO 1 YES D D M M M Y Y H H M M 0 NO 1 YES 24 HR. CLOCK H H M M
  • 2. STUDY MEDICATION WAS A NEW STUDY MEDICATION KIT DISPENSED? 0 NO 1 YES KIT NUMBER DISPENSED AT THIS VISIT: DATE AND TIME OF DOSE TAKEN AT THIS VISIT: DATE TIME NUMBER TAKEN PER BOTTLE SMEDDISP006 24 HR. CLOCK BOTTLE A BOTTLE B D D M M M Y Y H H M M
  • 3. OTHER TREATMENT IS THE SUBJECT IN DOSE GROUP 2? 0 NO 1 YES IF YES, COMPLETE BELOW TREATMENT WAS DOSE ADMINISTERED? DATE OF DOSE TIME OF DOSE 24 HR. CLOCK RITONAVIR 200 mg 0 NO 1 YES D D M M M Y Y H H M M
  • 4. DOSING - DAY 1 START DATE OF INFUSION START TIME OF INFUSION STOP DATE OF INFUSION STOP TIME OF INFUSION 24 HR. CLOCK 24 HR. CLOCK D D M M M Y Y H H M M D D M M M Y Y H H M M D WEIGHT OF A TOTAL DOSE DELIVERED INFUSATE DELIVERED Y 1 mg g SITE OF INFUSION: 1 LEFT ARM 2 RIGHT ARM 3 CENTRAL LINE 98 OTHER (SPECIFY) DOSING CHANGES S NO YE REASON SPECIFY 0 1 WAS DOSE OMITTED? D A Y WAS THE INFUSION TEMPORARILY INTERRUPTED? INTERRUPTION DURATION: 1 1 MIN 2 HR DOSE OMITTED REASONS 9 = DELAYED HEMATOLOGIC RECOVERY 12 = DELAYED NON-HEMATOLOGIC RECOVERY (SPECIFY) 98 = OTHER (SPECIFY) INFUSION INTERRUPTED REASONS 8 = HYPERSENSITIVITY REACTION 17 = ADVERSE EVENT (SPECIFY) 98 = OTHER (SPECIFY)
  • 5. RECORD OF STUDY MEDICATION WAS THE DOSE ADMINISTERED? 0 NO 1 YES TREATMENT DATE OF DOSE TIME OF DOSE 24 HR. CLOCK A B C D D M M M Y Y H H M M
  • 6. RECORD OF STUDY MEDICATION WAS THE DOSE ADMINISTERED? 0 NO 1 YES DOSE GROUP DATE OF DOSE TIME OF DOSE (MARK ONE) 24 HR. CLOCK 1 2 3 4 5 6 D D M M M Y Y H H M M
  • 7. RECORD OF STUDY MEDICATION TREATMENT DATE OF DOSE TIME OF DOSE 24 HR. CLOCK BMS-298585 10 mg D D M M M Y Y H H M M RECORD OF STUDY MEDICATION WAS THE DOSE ADMINISTERED? 0 NO 1 YES TREATMENT DATE OF DOSE TIME OF DOSE 24 HR. CLOCK D D M M M Y Y H H M M RECORD OF STUDY MEDICATION WAS THE DOSE ADMINISTERED? DATE OF DOSE TIME OF DOSE 24 HR. CLOCK 0 NO 1 YES D D M M M Y Y H H M M
  • 8. DRUG ADMINISTRATION WAS THE DOSE ADMINISTERED? 0 NO 1 YES START TIME STOP TIME TREATMENT DATE ADMINISTERED? OF INFUSION OF INFUSION 24 HR. CLOCK 24 HR. CLOCK A B D D M M M Y Y H H M M H H M M WAS FULL INFUSION COMPLETED? 0 NO 1 YES TOTAL DOSE ADMINISTERED? mg