Meal And Smed Modules Part Two

MEAL SCHEDULE

MEAL

M M

24 HR. CLOCK

H H

M M

24 HR. CLOCK

H H

WAS THE MEALADMINISTERED?

(MARK ONE)

D D M M M Y Y

DATE OF MEAL

MEAL SCHEDULE

MEAL

D D M M M Y Y

DATE OF MEAL

HIGH-FAT

RELATIVETIME

AM

START TIMESTOP TIME

WAS THE MEALCOMPLETED?(MARK ONE)

0 NO 1 YES0 NO 1 YES

WAS THE MEALADMINISTERED?

(MARK ONE)

0 NO 1 YES M M

24 HR. CLOCK

H H

M M

24 HR. CLOCK

H H

START TIMESTOP TIME

WAS THE MEALCOMPLETED?(MARK ONE)

0 NO 1 YES

WAS A NEW STUDY MEDICATION KIT DISPENSED?

KIT NUMBER DISPENSED AT THIS VISIT:

DATE AND TIME OF DOSE TAKEN AT THIS VISIT:

DATE TIME NUMBER TAKEN PER BOTTLE

BOTTLE A BOTTLE B

STUDY MEDICATION

D D M M M Y Y M M

24 HR. CLOCK

H H

0 NO 1 YES

SMED

DISP006

OTHER TREATMENT

D D M M M Y Y M M

24 HR. CLOCK

H HRITONAVIR 200 mg

0 NO 1 YESIS THE SUBJECT IN DOSE GROUP 2? IF YES, COMPLETE BELOW

TREATMENT DATE OF DOSE TIME OF DOSEWAS DOSE ADMINISTERED?

0 NO 1 YES

DOSING - DAY 1

DAY

1

START DATE OF INFUSION

D D M M M Y Y

STOP DATE OF INFUSIONSTART TIME OF INFUSION STOP TIME OF INFUSION

mg

TOTAL DOSE DELIVERED

M M

24 HR. CLOCK

H H M M

24 HR. CLOCK

H H

DOSING CHANGES

WAS DOSE OMITTED?

WAS THE INFUSION TEMPORARILY INTERRUPTED?INTERRUPTION DURATION:

1 MIN 2 HR

DOSE OMITTED REASONS

9 = DELAYED HEMATOLOGIC RECOVERY12 = DELAYED NON-HEMATOLOGIC RECOVERY (SPECIFY)98 = OTHER (SPECIFY)

INFUSION INTERRUPTED REASONS8 = HYPERSENSITIVITY REACTION

17 = ADVERSE EVENT (SPECIFY)98 = OTHER (SPECIFY)

REASON SPECIFY0 1

NO

YES

DAY

1

g

WEIGHT OFINFUSATE DELIVERED

SITE OF INFUSION:1 LEFT ARM 2 RIGHT ARM

3 CENTRAL LINE 98 OTHER (SPECIFY)

D D M M M Y Y

RECORD OF STUDY MEDICATION

D D M M M Y Y M M

24 HR. CLOCK

H H

A B C

TREATMENT DATE OF DOSE TIME OF DOSE

WAS THE DOSE ADMINISTERED? 0 NO 1 YES

RECORD OF STUDY MEDICATION

DOSE GROUP DATE OF DOSE TIME OF DOSE(MARK ONE)

D D M M M Y Y M M

24 HR. CLOCK

H H

1 2 3

4 5 6

WAS THE DOSE ADMINISTERED? 0 NO 1 YES

RECORD OF STUDY MEDICATION

D D M M M Y Y M M

24 HR. CLOCK

H H

BMS-298585 10 mg

TREATMENT TIME OF DOSEDATE OF DOSE

RECORD OF STUDY MEDICATION

TREATMENT DATE OF DOSE TIME OF DOSE

D D M M M Y Y M M

24 HR. CLOCK

H H

WAS THE DOSE ADMINISTERED? 0 NO 1 YES

RECORD OF STUDY MEDICATION

D D M M M Y Y M M

24 HR. CLOCK

H H

WAS THE DOSE ADMINISTERED?

0 NO 1 YES

DATE OF DOSE TIME OF DOSE

DRUG ADMINISTRATION

D D M M M Y Y M M

24 HR. CLOCK

H H M M

24 HR. CLOCK

H H

A B

0 NO 1 YES

WAS THE DOSE ADMINISTERED? 0 NO 1 YES

TREATMENTSTART TIMEOF INFUSION

STOP TIMEOF INFUSION

DATE ADMINISTERED?

WAS FULL INFUSION COMPLETED?

TOTAL DOSE ADMINISTERED? mg