**REGISTRATION**

+-------------------+-------------+---+---+----+------+------------------+
| INSTITUTION CODE  | PARTICIPANT | V |   |    |      | VISIT DATE       |
|                   | ID          | I |   |    |      |                  |
| \_\_\_\_\_\_\_\   |             | S |   |    |      | *(MM/DD/YYYY)*   |
| _\_\_\_\_\_\_\_\_ | \_\_\_\_\_  | I |   |    |      |                  |
| \_\_\_\_\_\_\_\_\ | \_\_\_\_\_\ | T |   |    |      | \_\_\_ \_\_\_ /  |
| _\_\_\_\_\_\_\_\_ | _\_\_\_\_\_ | T |   |    |      | \_\_\_ \_\_\_ /  |
|                   |             | Y |   |    |      | \_\_\_ \_\_\_    |
|                   |             | P |   |    |      | \_\_\_ \_\_\_    |
|                   |             | E |   |    |      |                  |
|                   |             |   |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
|                   |             | \ |   |    |      |                  |
|                   |             | _ |   |    |      |                  |
+-------------------+-------------+---+---+----+------+------------------+
|                   |             |   |   |    |      |                  |
+-------------------+-------------+---+---+----+------+------------------+
| Gender: Male      |             |   |   | Ye |      |                  |
| Female Unknown    |             |   |   | ar |      |                  |
|                   |             |   |   | of |      |                  |
|                   |             |   |   | B  |      |                  |
|                   |             |   |   | ir |      |                  |
|                   |             |   |   | th |      |                  |
|                   |             |   |   | *  |      |                  |
|                   |             |   |   | (Y |      |                  |
|                   |             |   |   | YY |      |                  |
|                   |             |   |   | Y) |      |                  |
|                   |             |   |   | *: |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
|                   |             |   |   | \_ |      |                  |
+-------------------+-------------+---+---+----+------+------------------+
| Race: *check one  |             |   |   |    | Et   |                  |
| or more* White    |             |   |   |    | hnic |                  |
|                   |             |   |   |    | ity: |                  |
| Black or African  |             |   |   |    | Hisp |                  |
| American          |             |   |   |    | anic |                  |
|                   |             |   |   |    | or   |                  |
| Native Hawaiian   |             |   |   |    | La   |                  |
| or Other Pacific  |             |   |   |    | tino |                  |
| Islander          |             |   |   |    |      |                  |
|                   |             |   |   |    | Not  |                  |
| Asian             |             |   |   |    | Hisp |                  |
|                   |             |   |   |    | anic |                  |
| American Indian   |             |   |   |    | or   |                  |
| or Alaska Native  |             |   |   |    | La   |                  |
|                   |             |   |   |    | tino |                  |
| Unknown           |             |   |   |    |      |                  |
|                   |             |   |   |    | Unk  |                  |
|                   |             |   |   |    | nown |                  |
+-------------------+-------------+---+---+----+------+------------------+
| Date Informed     |             |   | D |    |      |                  |
|                   |             |   | a |    |      |                  |
| Consent Signed:   |             |   | t |    |      |                  |
| \_\_\_ \_\_\_ /   |             |   | e |    |      |                  |
| \_\_\_ \_\_\_ /   |             |   | o |    |      |                  |
| \_\_\_ \_\_\_     |             |   | f |    |      |                  |
| \_\_\_ \_\_\_     |             |   | R |    |      |                  |
|                   |             |   | e |    |      |                  |
| *(MM/DD/YYYY)*    |             |   | g |    |      |                  |
|                   |             |   | i |    |      |                  |
|                   |             |   | s |    |      |                  |
|                   |             |   | t |    |      |                  |
|                   |             |   | r |    |      |                  |
|                   |             |   | a |    |      |                  |
|                   |             |   | t |    |      |                  |
|                   |             |   | i |    |      |                  |
|                   |             |   | o |    |      |                  |
|                   |             |   | n |    |      |                  |
|                   |             |   | : |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | / |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | / |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   | \ |    |      |                  |
|                   |             |   | _ |    |      |                  |
|                   |             |   |   |    |      |                  |
|                   |             |   | * |    |      |                  |
|                   |             |   | ( |    |      |                  |
|                   |             |   | M |    |      |                  |
|                   |             |   | M |    |      |                  |
|                   |             |   | / |    |      |                  |
|                   |             |   | D |    |      |                  |
|                   |             |   | D |    |      |                  |
|                   |             |   | / |    |      |                  |
|                   |             |   | Y |    |      |                  |
|                   |             |   | Y |    |      |                  |
|                   |             |   | Y |    |      |                  |
|                   |             |   | Y |    |      |                  |
|                   |             |   | ) |    |      |                  |
|                   |             |   | * |    |      |                  |
|                   |             |   |   |    |      |                  |
|                   |             |   | N |    |      |                  |
|                   |             |   | o |    |      |                  |
|                   |             |   | t |    |      |                  |
|                   |             |   | A |    |      |                  |
|                   |             |   | p |    |      |                  |
|                   |             |   | p |    |      |                  |
|                   |             |   | l |    |      |                  |
|                   |             |   | i |    |      |                  |
|                   |             |   | c |    |      |                  |
|                   |             |   | a |    |      |                  |
|                   |             |   | b |    |      |                  |
|                   |             |   | l |    |      |                  |
|                   |             |   | e |    |      |                  |
+-------------------+-------------+---+---+----+------+------------------+
| Does the          |             |   |   |    |      |                  |
| participant       |             |   |   |    |      |                  |
| satisfy all of    |             |   |   |    |      |                  |
| the eligibility   |             |   |   |    |      |                  |
| criteria? Yes No  |             |   |   |    |      |                  |
+-------------------+-------------+---+---+----+------+------------------+

**RANDOMIZATION**

+-------------------+-------------+---+---+----------+------------------+
| INSTITUTION CODE  | PARTICIPANT | V |   |          | VISIT DATE       |
|                   | ID          | I |   |          |                  |
| \_\_\_\_\_\_\_\   |             | S |   |          | *(MM/DD/YYYY)*   |
| _\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | I |   |          |                  |
| \_\_\_\_\_\_\_\_\ | _\_\_\_\_\_ | T |   |          | \_\_\_ \_\_\_ /  |
| _\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | T |   |          | \_\_\_ \_\_\_ /  |
|                   | _\_\_\_\_\_ | Y |   |          | \_\_\_ \_\_\_    |
|                   |             | P |   |          | \_\_\_ \_\_\_    |
|                   |             | E |   |          |                  |
|                   |             |   |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
+-------------------+-------------+---+---+----------+------------------+
|                   |             |   |   |          |                  |
+-------------------+-------------+---+---+----------+------------------+
| Date Run-In       |             | D |   |          |                  |
| Started: \_\_\_   |             | a |   |          |                  |
| \_\_\_ / \_\_\_   |             | t |   |          |                  |
| \_\_\_ / \_\_\_   |             | e |   |          |                  |
| \_\_\_ \_\_\_     |             | R |   |          |                  |
| \_\_\_\           |             | u |   |          |                  |
| *(MM/DD/YYYY)*    |             | n |   |          |                  |
|                   |             | - |   |          |                  |
|                   |             | I |   |          |                  |
|                   |             | n |   |          |                  |
|                   |             | E |   |          |                  |
|                   |             | n |   |          |                  |
|                   |             | d |   |          |                  |
|                   |             | e |   |          |                  |
|                   |             | d |   |          |                  |
|                   |             | : |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | / |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | / |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | _ |   |          |                  |
|                   |             | \ |   |          |                  |
|                   |             | * |   |          |                  |
|                   |             | ( |   |          |                  |
|                   |             | M |   |          |                  |
|                   |             | M |   |          |                  |
|                   |             | / |   |          |                  |
|                   |             | D |   |          |                  |
|                   |             | D |   |          |                  |
|                   |             | / |   |          |                  |
|                   |             | Y |   |          |                  |
|                   |             | Y |   |          |                  |
|                   |             | Y |   |          |                  |
|                   |             | Y |   |          |                  |
|                   |             | ) |   |          |                  |
|                   |             | * |   |          |                  |
+-------------------+-------------+---+---+----------+------------------+
| Does the          |             |   |   |          |                  |
| participant       |             |   |   |          |                  |
| satisfy all of    |             |   |   |          |                  |
| the randomization |             |   |   |          |                  |
| criteria? Yes No  |             |   |   |          |                  |
+-------------------+-------------+---+---+----------+------------------+
| Date Participant  |             |   |   | Rando    |                  |
| Randomized:       |             |   |   | mization |                  |
| \_\_\_ \_\_\_ /   |             |   |   | Number:  |                  |
| \_\_\_ \_\_\_ /   |             |   |   | \_\_\_   |                  |
| \_\_\_ \_\_\_     |             |   |   | \_\_\_   |                  |
| \_\_\_ \_\_\_\    |             |   |   | \_\_\_   |                  |
| *(MM/DD/YYYY)*    |             |   |   | \_\_\_   |                  |
|                   |             |   |   | \_\_\_   |                  |
+-------------------+-------------+---+---+----------+------------------+
|                   |             |   |   |          |                  |
+-------------------+-------------+---+---+----------+------------------+
| Agent Name:       |             |   |   |          |                  |
| \_\_\_\_\_\_      |             |   |   |          |                  |
| \_\_\_\_\_\_\_\_\ |             |   |   |          |                  |
| _\_\_\_\_\_\_\_\_ |             |   |   |          |                  |
| \_\_\_\_\_\_\_\_\ |             |   |   |          |                  |
| _\_\_\_\_\_\_\_\_ |             |   |   |          |                  |
|                   |             |   |   |          |                  |
| Agent Dose:       |             |   |   |          |                  |
| \_\_\_\_\         |             |   |   |          |                  |
| _\_\_\_\_\_\_\_\_ |             |   |   |          |                  |
| Units:            |             |   |   |          |                  |
| \_\_\_\_\         |             |   |   |          |                  |
| _\_\_\_\_\_\_\_\_ |             |   |   |          |                  |
| Frequency:        |             |   |   |          |                  |
| \_\_\_\_\_\_\_\_\ |             |   |   |          |                  |
| _\_\_\_\_\_\_\_\_ |             |   |   |          |                  |
+-------------------+-------------+---+---+----------+------------------+
| Date Agent        |             |   | > |          |                  |
| Provided (to      |             |   |   |          |                  |
| participant):     |             |   | D |          |                  |
| \_\_ \_\_ / \_\_  |             |   | a |          |                  |
| \_\_ / \_\_ \_\_  |             |   | t |          |                  |
| \_\_ \_\_         |             |   | e |          |                  |
|                   |             |   | > |          |                  |
| *(MM/DD/YYYY)*    |             |   |   |          |                  |
|                   |             |   | A |          |                  |
|                   |             |   | g |          |                  |
|                   |             |   | e |          |                  |
|                   |             |   | n |          |                  |
|                   |             |   | t |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | S |          |                  |
|                   |             |   | t |          |                  |
|                   |             |   | a |          |                  |
|                   |             |   | r |          |                  |
|                   |             |   | t |          |                  |
|                   |             |   | e |          |                  |
|                   |             |   | d |          |                  |
|                   |             |   | : |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | / |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | / |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | \ |          |                  |
|                   |             |   | _ |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   | > |          |                  |
|                   |             |   |   |          |                  |
|                   |             |   | * |          |                  |
|                   |             |   | ( |          |                  |
|                   |             |   | M |          |                  |
|                   |             |   | M |          |                  |
|                   |             |   | / |          |                  |
|                   |             |   | D |          |                  |
|                   |             |   | D |          |                  |
|                   |             |   | / |          |                  |
|                   |             |   | Y |          |                  |
|                   |             |   | Y |          |                  |
|                   |             |   | Y |          |                  |
|                   |             |   | Y |          |                  |
|                   |             |   | ) |          |                  |
|                   |             |   | * |          |                  |
+-------------------+-------------+---+---+----------+------------------+

**BASELINE MEDICAL/SURGICAL HISTORY**

+--------------------+---+------+----+---+------------+-----------------+
| INSTITUTION CODE   | P |      |    | V |            | VISIT DATE      |
|                    | A |      |    | I |            |                 |
| \_\_\_\_\_\_       | R |      |    | S |            | *(MM/DD/YYYY)*  |
| \_\_\_\_\_\_\_\_\_ | T |      |    | I |            |                 |
| \_\_\_\_\_\_\_\_\_ | I |      |    | T |            | \_\_\_ \_\_\_ / |
| \_\_\_\_\_\_\_\_\_ | C |      |    | T |            | \_\_\_ \_\_\_ / |
|                    | I |      |    | Y |            | \_\_\_ \_\_\_   |
|                    | P |      |    | P |            | \_\_\_ \_\_\_   |
|                    | A |      |    | E |            |                 |
|                    | N |      |    |   |            |                 |
|                    | T |      |    | \ |            |                 |
|                    | I |      |    | _ |            |                 |
|                    | D |      |    | \ |            |                 |
|                    |   |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    | \ |      |    | \ |            |                 |
|                    | _ |      |    | _ |            |                 |
|                    |   |      |    | \ |            |                 |
|                    |   |      |    | _ |            |                 |
|                    |   |      |    | \ |            |                 |
|                    |   |      |    | _ |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
|                    |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Body System        |   | No   | Ab |   | Comments   |                 |
|                    |   | rmal | no |   | (Required  |                 |
|                    |   |      | rm |   | if         |                 |
|                    |   |      | al |   | Abnormal)  |                 |
+--------------------+---+------+----+---+------------+-----------------+
| H/E/E/N/T          |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Neck               |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Respiratory        |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Cardiovascular     |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Gastrointestinal   |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Musculoskeletal    |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Dermatologic       |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| H                  |   |      |    |   |            |                 |
| ematopoietic/Lymph |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| E                  |   |      |    |   |            |                 |
| ndocrine/Metabolic |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Genitourinary      |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Breasts            |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Neurologic         |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+
| Allergy/Drug       |   |      |    |   |            |                 |
| Sensitivity        |   |      |    |   |            |                 |
+--------------------+---+------+----+---+------------+-----------------+

  ------------------------------------------------------ -------- ---------- -------------------------------
  Specify Other Body System/Site                         Normal   Abnormal   Comments (Required if Abnormal)

  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                       

  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                       

  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                       
  ------------------------------------------------------ -------- ---------- -------------------------------

**BASELINE SYMPTOMS**

<table style="width:100%;">
<colgroup>
<col style="width: 3%" />
<col style="width: 25%" />
<col style="width: 1%" />
<col style="width: 3%" />
<col style="width: 14%" />
<col style="width: 8%" />
<col style="width: 3%" />
<col style="width: 6%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 25%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="2"><p>INSTITUTION CODE</p>
<p>_________________________________</p></td>
<td colspan="3"><p>PARTICIPANT ID</p>
<p>______________________</p></td>
<td colspan="5"><p>VISIT TYPE</p>
<p>__________________________</p></td>
<td><p>VISIT DATE</p>
<p><em>(MM/DD/YYYY)</em></p>
<p>___ ___ / ___ ___ / ___ ___ ___ ___</p></td>
</tr>
<tr class="even">
<td></td>
<td colspan="3"></td>
<td colspan="3"></td>
<td colspan="2"></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="3">Symptom Description</td>
<td colspan="3"><p>Onset Date</p>
<p><em>(MM/DD/YYYY)</em></p></td>
<td colspan="2"><p>Severity*</p>
<p>(Grade)</p></td>
<td colspan="3">Comments</td>
</tr>
<tr class="even">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="odd">
<td colspan="3"></td>
<td colspan="3">___ ___ / ___ ___ / ___ ___ ___ ___</td>
<td colspan="2"></td>
<td colspan="3"></td>
</tr>
<tr class="even">
<td colspan="11">*Severity (Grade)</td>
</tr>
<tr class="odd">
<td colspan="11"><p>1 = Mild</p>
<p>2 = Moderate</p>
<p>3 = Severe</p>
<p>4 = Life-threatening</p></td>
</tr>
</tbody>
</table>

**PHYSICAL EXAM**

+----------------+---+---+------------+---+----+-------+------------+----+
| INSTITUTION    |   | P |            | V |    |       | VISIT DATE |    |
| CODE           |   | A |            | I |    |       |            |    |
|                |   | R |            | S |    |       | *(MM       |    |
| \_\_\_\_\_     |   | T |            | I |    |       | /DD/YYYY)* |    |
| \_\_\_\_\_\_\_ |   | I |            | T |    |       |            |    |
| \_\_\_\_\_\_\_ |   | C |            | T |    |       | \_\_\_     |    |
| \_\_\_\_\_\_\_ |   | I |            | Y |    |       | \_\_\_ /   |    |
| \_\_\_\_\_\_\_ |   | P |            | P |    |       | \_\_\_     |    |
|                |   | A |            | E |    |       | \_\_\_ /   |    |
|                |   | N |            |   |    |       | \_\_\_     |    |
|                |   | T |            | \ |    |       | \_\_\_     |    |
|                |   | I |            | _ |    |       | \_\_\_     |    |
|                |   | D |            | \ |    |       | \_\_\_     |    |
|                |   |   |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   | \ |            | \ |    |       |            |    |
|                |   | _ |            | _ |    |       |            |    |
|                |   |   |            | \ |    |       |            |    |
|                |   |   |            | _ |    |       |            |    |
|                |   |   |            | \ |    |       |            |    |
|                |   |   |            | _ |    |       |            |    |
+----------------+---+---+------------+---+----+-------+------------+----+
|                |   |   |            |   |    |       |            |    |
+----------------+---+---+------------+---+----+-------+------------+----+
| Examination    |   |   |            |   |    |       |            |    |
| Date           |   |   |            |   |    |       |            |    |
| *              |   |   |            |   |    |       |            |    |
| (MM/DD/YYYY):* |   |   |            |   |    |       |            |    |
| \_\_\_ \_\_\_  |   |   |            |   |    |       |            |    |
| / \_\_\_       |   |   |            |   |    |       |            |    |
| \_\_\_ /       |   |   |            |   |    |       |            |    |
| \_\_\_ \_\_\_  |   |   |            |   |    |       |            |    |
| \_\_\_ \_\_\_  |   |   |            |   |    |       |            |    |
+----------------+---+---+------------+---+----+-------+------------+----+
| Height: \_\_\_ |   |   | Weight:    |   |    | Te    |            |    |
| \_\_\_ \_\_\_  | c |   | \_\_\_     |   | kg | mpera |            | °C |
| **.** \_\_\_   | m |   | \_\_\_     |   |    | ture: |            |    |
| \_\_\_         |   |   | \_\_\_     |   | lb | \     |            | °F |
|                | i |   | **.**      |   |    | _\_\_ |            |    |
| Not Obtained   | n |   | \_\_\_     |   |    | \     |            |    |
|                |   |   | \_\_\_     |   |    | _\_\_ |            |    |
|                |   |   |            |   |    | \     |            |    |
|                |   |   | Not        |   |    | _\_\_ |            |    |
|                |   |   | Obtained   |   |    | **.** |            |    |
|                |   |   |            |   |    | \     |            |    |
|                |   |   |            |   |    | _\_\_ |            |    |
|                |   |   |            |   |    | \     |            |    |
|                |   |   |            |   |    | _\_\_ |            |    |
|                |   |   |            |   |    |       |            |    |
|                |   |   |            |   |    | Not   |            |    |
|                |   |   |            |   |    | Obt   |            |    |
|                |   |   |            |   |    | ained |            |    |
+----------------+---+---+------------+---+----+-------+------------+----+
| Pulse Rate:    |   |   | R          |   |    | Blood |            |    |
| \_\_\_ \_\_\_  |   |   | espiration |   |    | Pres  |            |    |
| \_\_\_         |   |   | Rate:      |   |    | sure: |            |    |
|                |   |   | \_\_\_     |   |    | \_\_  |            |    |
| Not Obtained   |   |   | \_\_\_     |   |    | \_\_  |            |    |
|                |   |   | \_\_\_     |   |    | \_\_  |            |    |
|                |   |   |            |   |    | /     |            |    |
|                |   |   | Not        |   |    | \_\_  |            |    |
|                |   |   | Obtained   |   |    | \_\_  |            |    |
|                |   |   |            |   |    | \_\_  |            |    |
|                |   |   |            |   |    |       |            |    |
|                |   |   |            |   |    | Not   |            |    |
|                |   |   |            |   |    | Obt   |            |    |
|                |   |   |            |   |    | ained |            |    |
|                |   |   |            |   |    | Sys   |            |    |
|                |   |   |            |   |    | tolic |            |    |
|                |   |   |            |   |    | (mm   |            |    |
|                |   |   |            |   |    | Hg)   |            |    |
|                |   |   |            |   |    | Dias  |            |    |
|                |   |   |            |   |    | tolic |            |    |
|                |   |   |            |   |    | (mm   |            |    |
|                |   |   |            |   |    | Hg)   |            |    |
+----------------+---+---+------------+---+----+-------+------------+----+

ECOG Performance Status: 0 1 2 3 4

  ----------------- -------- ---------- ---------- ---------------------------
  Body System/Site  Normal   Abnormal   Not        Comments (Required if
                                        Examined   Abnormal)

  Appearance                                       

  Skin                                             

  H/E/E/N/T                                        

  Thyroid                                          

  Chest                                            

  Lungs                                            

  Breasts                                          

  Heart                                            

  Abdomen                                          

  Musculoskeletal                                  

  Genitalia                                        

  Pelvis                                           

  Rectal                                           

  Prostate                                         

  Vascular                                         

  Neurological                                     

  Lymph Nodes                                      
  ----------------- -------- ---------- ---------- ---------------------------

  ---------------------------------------- -------- ---------- ------------------------------------
  Specify Other Body System/Site           Normal   Abnormal   Comments (Required if Abnormal)

  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                       

  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                       

  \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                       
  ---------------------------------------- -------- ---------- ------------------------------------

**CONCOMITANT MEDICATIONS**

**CLINICAL LABORATORY DATA**

**HEMATOLOGY**

+--------------------+-------------+----------------+-----------------+
| INSTITUTION CODE   | PARTICIPANT | VISIT TYPE     | VISIT DATE      |
|                    | ID          |                |                 |
| \_\_\_\_\_\_       |             | \_\_\_\_\_     | *(MM/DD/YYYY)*  |
| \_\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | \_\_\_\_\_\_\_ |                 |
| \_\_\_\_\_\_\_\_\_ | _\_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ / |
| \_\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ / |
|                    | _\_\_\_\_\_ |                | \_\_\_ \_\_\_   |
|                    |             |                | \_\_\_ \_\_\_   |
+--------------------+-------------+----------------+-----------------+
|                    |             |                |                 |
+--------------------+-------------+----------------+-----------------+
| Date Specimen      |             |                |                 |
| Collected: \_\_    |             |                |                 |
| \_\_ / \_\_ \_\_ / |             |                |                 |
| \_\_ \_\_ \_\_     |             |                |                 |
| \_\_ Fasting: Yes  |             |                |                 |
| No Unknown         |             |                |                 |
|                    |             |                |                 |
| *(MM/DD/YYYY)*     |             |                |                 |
+--------------------+-------------+----------------+-----------------+

Please indicate results for all completed tests or check the Not
Obtained box if a test was not performed. Indicate if test is out of
range (as defined by the lab where the specimen was analyzed) and
provide the physician's assessment of clinical significance for
completed tests only.

<table>
<colgroup>
<col style="width: 18%" />
<col style="width: 6%" />
<col style="width: 12%" />
<col style="width: 7%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 10%" />
<col style="width: 23%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2">Lab Test</td>
<td rowspan="2"><blockquote>
<p>Not Obtained</p>
</blockquote></td>
<td rowspan="2">Result</td>
<td rowspan="2">Units</td>
<td colspan="2">Out of Range</td>
<td colspan="3">Clinically Significant</td>
<td rowspan="2">Comments</td>
</tr>
<tr class="even">
<td><blockquote>
<p><strong>YES</strong></p>
</blockquote></td>
<td><blockquote>
<p><strong>NO</strong></p>
</blockquote></td>
<td><strong>YES</strong></td>
<td><strong>NO</strong></td>
<td><strong>UNKNOWN</strong></td>
</tr>
<tr class="odd">
<td>Hemoglobin</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Hematocrit</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>RBC</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>WBC</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td><strong>DIFFERENTIAL</strong></td>
<td rowspan="2"></td>
<td rowspan="2"></td>
<td rowspan="2"></td>
<td rowspan="2"></td>
<td rowspan="2"><blockquote>
&#10;</blockquote></td>
<td rowspan="2"></td>
<td rowspan="2"><blockquote>
&#10;</blockquote></td>
<td rowspan="2"><blockquote>
&#10;</blockquote></td>
<td rowspan="2"></td>
</tr>
<tr class="even">
<td><blockquote>
<p>Neutrophils, %</p>
</blockquote></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>Lymphocytes, %</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td><blockquote>
<p>Monocytes, %</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>Bands, %</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td><blockquote>
<p>Eosinophils, %</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td><blockquote>
<p>Basophils, %</p>
</blockquote></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Platelet</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
</tbody>
</table>

**CLINICAL LABORATORY DATA**

**BLOOD CHEMISTRY**

+--------------------+-------------+----------------+-----------------+
| INSTITUTION CODE   | PARTICIPANT | VISIT TYPE     | VISIT DATE      |
|                    | ID          |                |                 |
| \_\_\_\_\_\_       |             | \_\_\_\_\_     | *(MM/DD/YYYY)*  |
| \_\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | \_\_\_\_\_\_\_ |                 |
| \_\_\_\_\_\_\_\_\_ | _\_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ / |
| \_\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ / |
|                    | _\_\_\_\_\_ |                | \_\_\_ \_\_\_   |
|                    |             |                | \_\_\_ \_\_\_   |
+--------------------+-------------+----------------+-----------------+
|                    |             |                |                 |
+--------------------+-------------+----------------+-----------------+
| Date Specimen      |             |                |                 |
| Collected: \_\_    |             |                |                 |
| \_\_ / \_\_ \_\_ / |             |                |                 |
| \_\_ \_\_ \_\_     |             |                |                 |
| \_\_ Fasting: Yes  |             |                |                 |
| No Unknown         |             |                |                 |
|                    |             |                |                 |
| *(MM/DD/YYYY)*     |             |                |                 |
+--------------------+-------------+----------------+-----------------+

Please indicate results for all completed tests or check the Not
Obtained box if a test was not performed. Indicate if test is out of
range (as defined by the lab where the specimen was analyzed) and
provide the physician's assessment of clinical significance for
completed tests only.

<table>
<colgroup>
<col style="width: 17%" />
<col style="width: 6%" />
<col style="width: 13%" />
<col style="width: 7%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 10%" />
<col style="width: 23%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2">Lab Test</td>
<td rowspan="2"><blockquote>
<p>Not Obtained</p>
</blockquote></td>
<td rowspan="2">Result</td>
<td rowspan="2">Units</td>
<td colspan="2">Out of Range</td>
<td colspan="3">Clinically Significant</td>
<td rowspan="2">Comments</td>
</tr>
<tr class="even">
<td><blockquote>
<p><strong>YES</strong></p>
</blockquote></td>
<td><blockquote>
<p><strong>NO</strong></p>
</blockquote></td>
<td><strong>YES</strong></td>
<td><strong>NO</strong></td>
<td><strong>UNKNOWN</strong></td>
</tr>
<tr class="odd">
<td>Total Protein</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Albumin</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>Calcium</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Phosphorus</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>Cholesterol</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Triglycerides</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>Glucose, Serum</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Uric Acid</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>BUN</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Creatinine</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>Bilirubin, Total</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Alkaline Phosphatase</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>Sodium</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Potassium</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>Chloride</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Bicarbonate</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>SGOT/AST</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>SGPT/ALT</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>LDH</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
</tbody>
</table>

**CLINICAL LABORATORY DATA**

**URINE**

+-------------------+-------------+----------------+------------------+
| INSTITUTION CODE  | PARTICIPANT | VISIT TYPE     | VISIT DATE       |
|                   | ID          |                |                  |
| \_\_\_\_\_\_\_\   |             | \_\_\_\_\_     | *(MM/DD/YYYY)*   |
| _\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | \_\_\_\_\_\_\_ |                  |
| \_\_\_\_\_\_\_\_\ | _\_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /  |
| _\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /  |
|                   | _\_\_\_\_\_ |                | \_\_\_ \_\_\_    |
|                   |             |                | \_\_\_ \_\_\_    |
+-------------------+-------------+----------------+------------------+
|                   |             |                |                  |
+-------------------+-------------+----------------+------------------+
| Date Specimen     |             |                |                  |
| Collected: \_\_   |             |                |                  |
| \_\_ / \_\_ \_\_  |             |                |                  |
| / \_\_ \_\_ \_\_  |             |                |                  |
| \_\_ Fasting: Yes |             |                |                  |
| No Unknown        |             |                |                  |
|                   |             |                |                  |
| *(MM/DD/YYYY)*    |             |                |                  |
+-------------------+-------------+----------------+------------------+

Please indicate results for all completed tests or check the Not
Obtained box if a test was not performed. Indicate if test is out of
range (as defined by the lab where the specimen was analyzed) and
provide the physician's assessment of clinical significance for
completed tests only.

<table>
<colgroup>
<col style="width: 17%" />
<col style="width: 6%" />
<col style="width: 13%" />
<col style="width: 7%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 6%" />
<col style="width: 5%" />
<col style="width: 10%" />
<col style="width: 23%" />
</colgroup>
<tbody>
<tr class="odd">
<td rowspan="2">Lab Test</td>
<td rowspan="2"><blockquote>
<p>Not Obtained</p>
</blockquote></td>
<td rowspan="2">Result</td>
<td rowspan="2">Units</td>
<td colspan="2">Out of Range</td>
<td colspan="3">Clinically Significant</td>
<td rowspan="2">Comments</td>
</tr>
<tr class="even">
<td><blockquote>
<p><strong>YES</strong></p>
</blockquote></td>
<td><blockquote>
<p><strong>NO</strong></p>
</blockquote></td>
<td><strong>YES</strong></td>
<td><strong>NO</strong></td>
<td><strong>UNKNOWN</strong></td>
</tr>
<tr class="odd">
<td>Appearance</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Specific Gravity</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>pH</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Protein</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>Glucose</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="even">
<td>Ketones</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
<tr class="odd">
<td>Blood</td>
<td></td>
<td></td>
<td></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
<td><blockquote>
&#10;</blockquote></td>
<td><blockquote>
&#10;</blockquote></td>
<td></td>
</tr>
</tbody>
</table>

**CLINICAL LABORATORY DATA**

**OTHER LAB TESTS**

+-------------------+-------------+----------------+------------------+
| INSTITUTION CODE  | PARTICIPANT | VISIT TYPE     | VISIT DATE       |
|                   | ID          |                |                  |
| \_\_\_\_\_\_\_\   |             | \_\_\_\_\_     | *(MM/DD/YYYY)*   |
| _\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | \_\_\_\_\_\_\_ |                  |
| \_\_\_\_\_\_\_\_\ | _\_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /  |
| _\_\_\_\_\_\_\_\_ | \_\_\_\_\_\ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /  |
|                   | _\_\_\_\_\_ |                | \_\_\_ \_\_\_    |
|                   |             |                | \_\_\_ \_\_\_    |
+-------------------+-------------+----------------+------------------+

+-----------------------------------------------------------------------+
| Date Specimen Collected: \_\_ \_\_ / \_\_ \_\_ / \_\_ \_\_ \_\_ \_\_  |
| Fasting: Yes No Unknown                                               |
|                                                                       |
| *(MM/DD/YYYY)*                                                        |
+-----------------------------------------------------------------------+

Please indicate the test name and results for all other completed tests.
Indicate if test is out of range (as defined by the lab where the
specimen was analyzed) and provide the physician's assessment of
clinical significance.

+--------------+---------+----+---+---+---+---+------+---------------+
| Lab Test     | Result  | U  | O |   | C |   |      | Comments      |
|              |         | ni | u |   | l |   |      |               |
|              |         | ts | t |   | i |   |      |               |
|              |         |    | o |   | n |   |      |               |
|              |         |    | f |   | i |   |      |               |
|              |         |    | R |   | c |   |      |               |
|              |         |    | a |   | a |   |      |               |
|              |         |    | n |   | l |   |      |               |
|              |         |    | g |   | l |   |      |               |
|              |         |    | e |   | y |   |      |               |
|              |         |    |   |   | S |   |      |               |
|              |         |    |   |   | i |   |      |               |
|              |         |    |   |   | g |   |      |               |
|              |         |    |   |   | n |   |      |               |
|              |         |    |   |   | i |   |      |               |
|              |         |    |   |   | f |   |      |               |
|              |         |    |   |   | i |   |      |               |
|              |         |    |   |   | c |   |      |               |
|              |         |    |   |   | a |   |      |               |
|              |         |    |   |   | n |   |      |               |
|              |         |    |   |   | t |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    | > | > | * | * | **U  |               |
|              |         |    |   |   | * | * | NKNO |               |
|              |         |    | * | * | Y | N | WN** |               |
|              |         |    | * | * | E | O |      |               |
|              |         |    | Y | N | S | * |      |               |
|              |         |    | E | O | * | * |      |               |
|              |         |    | S | * | * |   |      |               |
|              |         |    | * | * |   |   |      |               |
|              |         |    | * |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+
|              |         |    |   |   |   |   |      |               |
+--------------+---------+----+---+---+---+---+------+---------------+

**COMPLIANCE**

+----------------+--------------+----------------+--------------------+
| INSTITUTION    | PARTICIPANT  | VISIT TYPE     | VISIT DATE         |
| CODE           | ID           |                |                    |
|                |              | \_\_\_\_\_     | *(MM/DD/YYYY)*     |
| \_\_\_\_\_     | \_\_\_\_\_\_ | \_\_\_\_\_\_\_ |                    |
| \_\_\_\_\_\_\_ | \_\_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /    |
| \_\_\_\_\_\_\_ | \_\_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /    |
| \_\_\_\_\_\_\_ | \_\_\_\_\_\_ |                | \_\_\_ \_\_\_      |
|                |              |                | \_\_\_ \_\_\_      |
+----------------+--------------+----------------+--------------------+

+-----------------------------------------------------------------------+
| > **Current Intervention**                                            |
| >                                                                     |
| > Agent Name:                                                         |
| > \_\_\_\_\_\                                                         |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| >                                                                     |
| > Agent Dose: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Units:             |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Frequency:                           |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                  |
+-----------------------------------------------------------------------+
| > First Dose taken this period *(MM/DD/YYYY)*: \_\_ \_\_ / \_\_ \_\_  |
| > / \_\_ \_\_ \_\_ \_\_ Time *(hr:mm per 24 hr clock)*: \_\_ \_\_ :   |
| > \_\_ \_\_                                                           |
+-----------------------------------------------------------------------+
| > Last Dose taken this period *(MM/DD/YYYY)*: \_\_ \_\_ / \_\_ \_\_ / |
| > \_\_ \_\_ \_\_ \_\_ Time *(hr:mm per 24 hr clock)*: \_\_ \_\_ :     |
| > \_\_ \_\_                                                           |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > Was agent interrupted during this period? Yes No N/A                |
| >                                                                     |
| > If Yes, specify date stopped *(MM/DD/YYYY)*: \_\_\_ \_\_\_ / \_\_\_ |
| > \_\_\_ / \_\_\_ \_\_\_ \_\_\_ \_\_\_                                |
| >                                                                     |
| > Specify reason stopped:                                             |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\                       |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| >                                                                     |
| > Was agent restarted? Yes No N/A                                     |
| >                                                                     |
| > If Yes, specify date restarted *(MM/DD/YYYY)*: \_\_\_ \_\_\_ /      |
| > \_\_\_ \_\_\_ / \_\_\_ \_\_\_ \_\_\_ \_\_\_                         |
| >                                                                     |
| > Specify reason restarted:                                           |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\                                   |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > Was agent regimen modified during this period? Yes No N/A           |
| >                                                                     |
| > If Yes, specify date modified *(MM/DD/YYYY)*: \_\_\_ \_\_\_ /       |
| > \_\_\_ \_\_\_ / \_\_\_ \_\_\_ \_\_\_ \_\_\_                         |
| >                                                                     |
| > Specify new regimen: Dose: \_\_\_\_\_\_\_\_\_\_\_\_ Units:          |
| > \_\_\_\_\_\_\_\_\_\_\_\_ Frequency: \_\_\_\_\_\_\_\_\_\_\_          |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > Amount of agent provided at last visit:                             |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                        |
| >                                                                     |
| > Amount of agent returned this visit:                                |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                        |
| >                                                                     |
| > Amount of agent taken during this period:                           |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                        |
| >                                                                     |
| > Amount of agent missing/not accounted for this period:              |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                        |
+-----------------------------------------------------------------------+
| > Is the participant compliant with protocol intervention? Yes No     |
| > Unknown                                                             |
| >                                                                     |
| > If No, specify reason for noncompliance:                            |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\                                         |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| >                                                                     |
| > \_\_\_\_\_\_\_\_\_\_\_\_                                            |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > Was agent provided at this visit? Yes No N/A                        |
| >                                                                     |
| > Amount of agent provided at this visit:                             |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                    |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| > Comments:                                                           |
| > \_\_\_\_\_\_\_                                                      |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| >                                                                     |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| >                                                                     |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| >                                                                     |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| >                                                                     |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+

**ADVERSE EVENTS**

<table style="width:100%;">
<colgroup>
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 3%" />
<col style="width: 6%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 2%" />
<col style="width: 7%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 1%" />
<col style="width: 9%" />
<col style="width: 37%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="2"></td>
<td colspan="4"><p>INSTITUTION CODE</p>
<p>__________________________________</p></td>
<td colspan="4"><p>PARTICIPANT ID</p>
<p>_________________________________</p></td>
<td colspan="8"></td>
</tr>
<tr class="even">
<td colspan="14"><strong>At end of study only: check this box if
participant experienced no adverse events</strong>
<strong>None</strong></td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td><p>Adverse Event Reported Date</p>
<p><em>(MM/DD/YYYY)</em></p></td>
<td>Adverse Event Verbatim Term</td>
<td colspan="2"><p>CTC Adverse Event Term (v 3.0)</p>
<p>(Include Category &amp; AE Term)</p></td>
<td colspan="3"><p>Event Onset Date</p>
<p><em>(MM/DD/YYYY)</em></p></td>
<td><p>Event End Date</p>
<p><em>(MM/DD/YYYY)</em></p></td>
<td><blockquote>
<p>Severity (Grade)</p>
</blockquote></td>
<td colspan="2"><blockquote>
<p>Attribution</p>
</blockquote></td>
<td colspan="2"><blockquote>
<p>Reported as SAE?</p>
</blockquote></td>
<td colspan="2"><blockquote>
<p>Action</p>
</blockquote></td>
<td><blockquote>
<p>Outcome</p>
</blockquote></td>
<td>Comments</td>
<td></td>
</tr>
<tr class="even">
<td>__ __ / __ __ / __ __ __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="3">__ __ / __ __ / __ __ __ __</td>
<td>__ __ / __ __ / __ __ __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>__ __ / __ __ / __ __ __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="3">__ __ / __ __ / __ __ __ __</td>
<td>__ __ / __ __ / __ __ __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td>__ __ / __ __ / __ __ __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="3">__ __ / __ __ / __ __ __ __</td>
<td>__ __ / __ __ / __ __ __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="odd">
<td>Severity (Grade)</td>
<td colspan="2">Attribution: Relation to Study Agent</td>
<td colspan="2">Reported as SAE?</td>
<td colspan="7">Action</td>
<td colspan="5">Outcome</td>
<td></td>
</tr>
<tr class="even">
<td><p>1 = Mild</p>
<p>2 = Moderate</p>
<p>3 = Severe</p>
<p>4 = Life-threatening</p>
<p>5 = Fatal</p></td>
<td colspan="2"><p>1 = Unrelated</p>
<p>2 = Unlikely</p>
<p>3 = Possible</p>
<p>4 = Probable</p>
<p>5 = Definite</p></td>
<td colspan="2"><p>1 = Yes</p>
<p>2 = No</p></td>
<td colspan="7"><p>1 = Agent Withdrawn 5 = Unknown</p>
<p>2 = Agent Dose Reduced 6 = Not Applicable</p>
<p>3 = Agent Dose Increased</p>
<p>4 = Agent Dose Not Changed</p></td>
<td colspan="5"><p>1 = Resolved 5 = Fatal</p>
<p>2 = Resolving 6 = Unknown</p>
<p>3 = Not Resolved</p>
<p>4 = Resolved with sequelae</p></td>
<td></td>
</tr>
</tbody>
</table>

**OFF STUDY FORM**

+------+------------+------+------+--------+-------+----------+------+
|      | I          |      | PAR  |        | FORM  |          |      |
|      | NSTITUTION |      | TICI |        | DATE  |          |      |
|      | CODE       |      | PANT |        |       |          |      |
|      |            |      | ID   |        | *(MM  |          |      |
|      | \_\_\_     |      |      |        | /DD/Y |          |      |
|      | \_\_\_\_\_ |      | \_\_ |        | YYY)* |          |      |
|      | \_\_\_\_\_ |      | \_\_ |        |       |          |      |
|      | \_\_\_\_\_ |      | \_\_ |        | \     |          |      |
|      | \_\_\_\_\_ |      | \_\_ |        | _\_\_ |          |      |
|      | \_\_\_\_\_ |      | \_\_ |        | \     |          |      |
|      | \_\_\_\_\_ |      | \_\_ |        | _\_\_ |          |      |
|      |            |      | \_\_ |        | /     |          |      |
|      |            |      | \_\_ |        | \     |          |      |
|      |            |      | \_\_ |        | _\_\_ |          |      |
|      |            |      | \_\_ |        | \     |          |      |
|      |            |      | \_\_ |        | _\_\_ |          |      |
|      |            |      | \_\_ |        | /     |          |      |
|      |            |      | \_\_ |        | \     |          |      |
|      |            |      |      |        | _\_\_ |          |      |
|      |            |      |      |        | \     |          |      |
|      |            |      |      |        | _\_\_ |          |      |
|      |            |      |      |        | \     |          |      |
|      |            |      |      |        | _\_\_ |          |      |
|      |            |      |      |        | \     |          |      |
|      |            |      |      |        | _\_\_ |          |      |
+------+------------+------+------+--------+-------+----------+------+
|      |            |      |      |        |       |          |      |
+------+------------+------+------+--------+-------+----------+------+
| Date |            |      |      | Date   |       |          |      |
| on   |            |      |      | Off    |       |          |      |
| Fo   |            |      |      | Foll   |       |          |      |
| llow |            |      |      | ow-up: |       |          |      |
| -up: |            |      |      | \_\_\_ |       |          |      |
| \_   |            |      |      | \_\_\_ |       |          |      |
| \_\_ |            |      |      | /      |       |          |      |
| \_   |            |      |      | \_\_\_ |       |          |      |
| \_\_ |            |      |      | \_\_\_ |       |          |      |
| /    |            |      |      | /      |       |          |      |
| \_   |            |      |      | \_\_\_ |       |          |      |
| \_\_ |            |      |      | \_\_\_ |       |          |      |
| \_   |            |      |      | \_\_\_ |       |          |      |
| \_\_ |            |      |      | \_\_\_ |       |          |      |
| /    |            |      |      |        |       |          |      |
| \_   |            |      |      | *(     |       |          |      |
| \_\_ |            |      |      | MM/DD/ |       |          |      |
| \_   |            |      |      | YYYY)* |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
|      |            |      |      |        |       |          |      |
| *(   |            |      |      |        |       |          |      |
| MM/D |            |      |      |        |       |          |      |
| D/YY |            |      |      |        |       |          |      |
| YY)* |            |      |      |        |       |          |      |
+------+------------+------+------+--------+-------+----------+------+
| Date |            |      |      | Date   |       |          |      |
| Off  |            |      |      | of     |       |          |      |
| St   |            |      |      | Last   |       |          |      |
| udy: |            |      |      | Co     |       |          |      |
| \_   |            |      |      | ntact: |       |          |      |
| \_\_ |            |      |      | \_\_\_ |       |          |      |
| \_   |            |      |      | \_\_\_ |       |          |      |
| \_\_ |            |      |      | /      |       |          |      |
| /    |            |      |      | \_\_\_ |       |          |      |
| \_   |            |      |      | \_\_\_ |       |          |      |
| \_\_ |            |      |      | /      |       |          |      |
| \_   |            |      |      | \_\_\_ |       |          |      |
| \_\_ |            |      |      | \_\_\_ |       |          |      |
| /    |            |      |      | \_\_\_ |       |          |      |
| \_   |            |      |      | \_\_\_ |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      | *(     |       |          |      |
| \_\_ |            |      |      | MM/DD/ |       |          |      |
| \_   |            |      |      | YYYY)* |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
|      |            |      |      |        |       |          |      |
| *(   |            |      |      |        |       |          |      |
| MM/D |            |      |      |        |       |          |      |
| D/YY |            |      |      |        |       |          |      |
| YY)* |            |      |      |        |       |          |      |
+------+------------+------+------+--------+-------+----------+------+
| Date |            |      |      |        |       |          |      |
| Last |            |      |      |        |       |          |      |
| S    |            |      |      |        |       |          |      |
| tudy |            |      |      |        |       |          |      |
| A    |            |      |      |        |       |          |      |
| gent |            |      |      |        |       |          |      |
| Ta   |            |      |      |        |       |          |      |
| ken: |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| /    |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| /    |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
| \_   |            |      |      |        |       |          |      |
| \_\_ |            |      |      |        |       |          |      |
|      |            |      |      |        |       |          |      |
| *(   |            |      |      |        |       |          |      |
| MM/D |            |      |      |        |       |          |      |
| D/YY |            |      |      |        |       |          |      |
| YY)* |            |      |      |        |       |          |      |
+------+------------+------+------+--------+-------+----------+------+

+-----------------------------------------------------------------------+
| **Reason Off Study** (Please mark only the primary reason. Reasons    |
| **other than Completed Study** require explanation next to the        |
| response)                                                             |
+-----------------------------------------------------------------------+
| > Completed study                                                     |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > AE/SAE **(complete AE CRF & SAE form, if applicable)                |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\     |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** |
+-----------------------------------------------------------------------+
| > Lost to follow-up                                                   |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > Non-compliant participant                                           |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                    |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > Concomitant medication                                              |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > Medical contraindication                                            |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                                  |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > Withdraw consent                                                    |
| > \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_                    |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > Death **(complete Death Report CRF & SAE form)                      |
| > \_\_                                                                |
| **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+
| > Other                                                               |
| > \_\_\                                                               |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
+-----------------------------------------------------------------------+

**DEATH REPORT FORM**

+-------------------------+-------------------+-----------------------+
| INSTITUTION CODE        | PARTICIPANT ID    | FORM DATE             |
|                         |                   |                       |
| \_\_\_\_\_\_\_\_\_\_    | \_\_\_\_\_\_\_\_  | *(MM/DD/YYYY)*        |
| \_\_\_\_\_\_\_\_\_\_\_\ | \_\_\_\_\_\_\_\_\ |                       |
| _\_\_\_\_\_\_\_\_\_\_\_ | _\_\_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /       |
|                         |                   | \_\_\_ \_\_\_ /       |
|                         |                   | \_\_\_ \_\_\_ \_\_\_  |
|                         |                   | \_\_\_                |
+-------------------------+-------------------+-----------------------+

+-------------------------------+--------------------------------------+
| Date of Death *(MM/DD/YYYY):* |                                      |
| \_\_\_ \_\_\_ / \_\_\_ \_\_\_ |                                      |
| / \_\_\_ \_\_\_ \_\_\_ \_\_\_ |                                      |
+-------------------------------+--------------------------------------+
| Place of Death:               | Cause of Death:                      |
+-------------------------------+--------------------------------------+
| Hospital (attach discharge    | Study Agent                          |
| summary)                      |                                      |
|                               | Other, specify:                      |
| Other, specify:               | \_\_\_\_\_\_                         |
| \_\_\_\_\_\_\_\_\_\           | \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |
| _\_\_\_\_\_\_\_\_\_\_\_\_\_\_ |                                      |
|                               | Unknown                              |
| Unknown                       |                                      |
+-------------------------------+--------------------------------------+
| Autopsy performed? Yes        |                                      |
| [(attach autopsy report or    |                                      |
| send to NCI, DCP when         |                                      |
| available)]{.underline}       |                                      |
|                               |                                      |
| No                            |                                      |
|                               |                                      |
| Unknown                       |                                      |
+-------------------------------+--------------------------------------+

Comments:

**PHARMACOKINETICS FORM**

**BLOOD**

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 6%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 4%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 1%" />
<col style="width: 2%" />
<col style="width: 4%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 8%" />
<col style="width: 4%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td></td>
<td colspan="5"><p>INSTITUTION CODE</p>
<p>_________________________________</p></td>
<td colspan="4"><p>PARTICIPANT ID</p>
<p>______________________________</p></td>
<td colspan="4"><p>VISIT TYPE</p>
<p>_____________________________</p></td>
<td colspan="4"><p>VISIT DATE</p>
<p><em>(MM/DD/YYYY)</em></p>
<p>___ ___ / ___ ___ / ___ ___ ___ ___</p></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="5"></td>
<td colspan="6"></td>
<td colspan="5"></td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td colspan="2">Specimen #</td>
<td>Not Obtained</td>
<td><p>Date Specimen Collected</p>
<p><em>(MM/DD/YYYY)</em></p></td>
<td colspan="3">Specimen Amount</td>
<td>Scheduled Time</td>
<td><p>Scheduled Clock Time <em>(hr:mm per</em></p>
<p><em>24 hour clock)</em></p></td>
<td colspan="3"><p>Time Specimen were Collected <em>(hr:mm per</em></p>
<p><em>24 hour clock)</em></p></td>
<td>Result</td>
<td colspan="2">Units</td>
<td colspan="2">Other Result</td>
<td colspan="2"><p>Date Specimen Analyzed</p>
<p><em>(MM/DD/YYYY)</em></p></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
</tbody>
</table>

**PHARMACOKINETICS FORM**

**URINE**

<table>
<colgroup>
<col style="width: 5%" />
<col style="width: 0%" />
<col style="width: 6%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 4%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 1%" />
<col style="width: 2%" />
<col style="width: 4%" />
<col style="width: 10%" />
<col style="width: 3%" />
<col style="width: 1%" />
<col style="width: 5%" />
<col style="width: 4%" />
<col style="width: 9%" />
<col style="width: 4%" />
<col style="width: 2%" />
</colgroup>
<tbody>
<tr class="odd">
<td></td>
<td colspan="5"><p>INSTITUTION CODE</p>
<p>_________________________________</p></td>
<td colspan="4"><p>PARTICIPANT ID</p>
<p>_______________________________</p></td>
<td colspan="4"><p>VISIT TYPE</p>
<p>_____________________________</p></td>
<td colspan="4"><p>VISIT DATE</p>
<p><em>(MM/DD/YYYY)</em></p>
<p>___ ___ / ___ ___ / ___ ___ ___ ___</p></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="5"></td>
<td colspan="6"></td>
<td colspan="5"></td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td colspan="2">Specimen #</td>
<td>Not Obtained</td>
<td><p>Date Specimen Collected</p>
<p><em>(MM/DD/YYYY)</em></p></td>
<td colspan="3">Specimen Amount</td>
<td>Scheduled Time</td>
<td><p>Scheduled Clock Time <em>(hr:mm per</em></p>
<p><em>24 hour clock)</em></p></td>
<td colspan="3"><p>Time Specimen were Collected <em>(hr:mm per</em></p>
<p><em>24 hour clock)</em></p></td>
<td>Result</td>
<td colspan="2">Units</td>
<td colspan="2">Other Result</td>
<td colspan="2"><p>Date Specimen Analyzed</p>
<p><em>(MM/DD/YYYY)</em></p></td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td></td>
<td>_ _ / _ _ / _ _ _ _</td>
<td colspan="3"></td>
<td></td>
<td>__ __ : __ __</td>
<td colspan="3">__ __ : __ __</td>
<td></td>
<td colspan="2"></td>
<td colspan="2"><p> Not assayed</p>
<p> Below limit of</p>
<blockquote>
<p>detection</p>
</blockquote></td>
<td colspan="2">_ _ / _ _ / _ _ _ _</td>
<td></td>
</tr>
</tbody>
</table>

**COMMENTS**

+----------------+--------------+----------------+--------------------+
| INSTITUTION    | PARTICIPANT  | VISIT TYPE     | VISIT/FORM DATE    |
| CODE           | ID           |                |                    |
|                |              | \_\_\_\_\_     | *(MM/DD/YYYY)*     |
| \_\_\_\_\_     | \_\_\_\_\_\_ | \_\_\_\_\_\_\_ |                    |
| \_\_\_\_\_\_\_ | \_\_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /    |
| \_\_\_\_\_\_\_ | \_\_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /    |
| \_\_\_\_\_\_\_ | \_\_\_\_\_\_ |                | \_\_\_ \_\_\_      |
|                |              |                | \_\_\_ \_\_\_      |
+----------------+--------------+----------------+--------------------+

  -------- ----------- ----------------------------------------------------
  **FORM   **FIELD     **COMMENTS**
  CODE**   NAME**      

                       

                       

                       

                       

                       

                       

                       

                       

                       
  -------- ----------- ----------------------------------------------------

**VERIFICATION FORM**

+--------------------+------------+----------------+------------------+
| INSTITUTION CODE   | P          | VISIT TYPE     | FORM DATE        |
|                    | ARTICIPANT |                |                  |
| \_\_\_\_\_\_       | ID         | \_\_\_\_\_     | *(MM/DD/YYYY)*   |
| \_\_\_\_\_\_\_\_\_ |            | \_\_\_\_\_\_\_ |                  |
| \_\_\_\_\_\_\_\_\_ | \_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /  |
| \_\_\_\_\_\_\_\_\_ | \_\_\_\_\_ | \_\_\_\_\_\_\_ | \_\_\_ \_\_\_ /  |
|                    | \_\_\_\_\_ |                | \_\_\_ \_\_\_    |
|                    | \_\_\_\_\_ |                | \_\_\_ \_\_\_    |
+--------------------+------------+----------------+------------------+

The Investigator signature on this form should be obtained after ALL the
Case Report Forms for this participant have been completed.

**"I have reviewed all the Case Report Forms for the above participant
and agree that they are accurate and complete."**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
\_\_ \_\_ / \_\_ \_\_ / \_\_ \_\_ \_\_ \_\_

Investigator's Signature Date of Investigator's Signature

*(MM/DD/YYYY)*

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Investigator (PLEASE PRINT)