	<custodian>
		<assignedCustodian>
			<representedCustodianOrganization>
				<id extension="ABX_44445USA" root="2.1.3.4"/>
				<name>Good Health Clinic</name>
			</representedCustodianOrganization>
		</assignedCustodian>
	</custodian>
	<legalAuthenticator>
		<time value="20000408"/>
		<signatureCode code="S"/>
		<assignedEntity>
			<id extension="300-23" root="2.1.3.3"/>
			<assignedPerson>
				<name>
				<prefix>Dr.</prefix>
					<given>Jane</given>
					<family>Doe</family>
					<suffix>PhD</suffix>
				</name>
			</assignedPerson>
			<representedOrganization>
				<id extension="456897-99" root="2.1.5.3"/>
			</representedOrganization>
		</assignedEntity>
	</legalAuthenticator>
	<participant typeCode="RESP">
		<associatedEntity classCode="CRINV">
			<associatedPerson classCode="PSN">
				<name>Dr. Jane Doe</name><!--Investigator Name-->
			</associatedPerson>
			<scopingOrganization classCode="ORG" determinerCode="INSTANCE">
				<id nullFlavor="UNK" extension="0001"></id>
			</scopingOrganization>
		</associatedEntity>
	</participant>
	<componentOf typeCode="COMP">
		<encompassingEncounter>
			<id extension="5323" root="2.1.3.5"/>
			<effectiveTime nullFlavor="NA"/>
			<location typeCode="LOC">
				<healthCareFacility>
					<id extension="18-334A" root="2.1.3.6"/>
				</healthCareFacility>
			</location>
		</encompassingEncounter>
	</componentOf>

		<!-- 
********************************************************
Patient Narrative Content
********************************************************
-->
	<component>
		<structuredBody>
			<component>
				<section>
				<code code="0001" codeSystem="2.1.6.4"/>
				<title>Reason for Narrative</title>
				<text>
				<list>
					<item ID="pd0"></item>
				</list>
				</text>
				<entry>
					<observation classCode="OBS" moodCode="EVN">
					<code code="C99097" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Reason for Narrative"/>
					<value xsi:type="CE">
					<translation code="xxxxx" codeSystem="2.16.840.1.113883.6.1" displayName="LOINC"/>
					</value>
					</observation></entry>
				</section>
				</component>
				<component>
				<section>
					<code code="C41331" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI EVS"/>
					<title>Adverse Events</title>
					<text>
						<list>
							<item ID="pd1">Vomiting</item>
						</list>
					</text>
					<entry>
						<observation classCode="OBS" moodCode="EVN">
							<code code="C41331" displayName="Adverse Event" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI EVS" />
							<value xsi:type="ED" mediaType="text/plain">Vomiting</value>
						</observation>
					</entry>
				</section>
			</component>
			<component>
				<section>
					<code code="C99098" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI EVS" displayName="Actual Arm"/>
					<title>Actual Arm Information</title>
					<text>
						<list>
							<item>
								<content ID="pns1">Treatment A</content>
							</item>
							<item ID="pns2">This patient was a 50-year-old, White female. The patient’s first relapse was in
October 2007 (exact date not available). The patient’s Baseline score was 2.0.
Notable in this patient’s medical history were hypothyroidism, facial pain,
intervertebral disc degeneration, thyroid neoplasm, cervicobrachial syndrome,
breast mass, sinus polyp, tonsillectomy, and hypertension. The relevant
concomitant medications upon study entry were hydrochlorothiazide, acetylsalicylic acid,
and levothyroxine.
The last dose of study drug prior to the event was 23 May 2008. On Day 325 (08 Apr
2009), the patient was noted with grade 3 thyroid cancer (papillary thyroid
carcinoma) requiring surgical intervention. On the same day, the patient underwent right
thyroid lobectomy. The pathology report from the right thyroid lobectomy revealed a 4
cm follicular adenoma, as well as 2 incidental microscopic foci of papillary carcinoma
with the larger focus measuring 3.5 mm. The post-operative pathology examination
conducted on Day 327 (10 April 2009) revealed a microscopic papillary thyroid
carcinoma, confined by the thyroid capsule. The thyroid function tests performed on Day
337 (20 Apr 2009) were normal with the thyroid stimulating hormone (TSH) at 5.45
mU/L (normal 0.40 - 5.50 mU/L), Free T4 at 14.2 pmol/L (normal 10.3-23.2 pmol/L) and
Free T3 at 5.2 pmol/L (normal 3.5 - 6.5 pmol/L). On the same day, the patient was
advised to have the left side of her thyroid gland removed due to the carcinoma findings
on the right side, and several rounds of radiation treatment after surgery. The study drug
was permanently discontinued on Day 341 (24 Apr 2009) due to the event of thyroid
cancer and levothyroxine was started from Day 342 (25 Apr 2009). On Day 388
(10 June 2009), the patient underwent left thyroid lobectomy with removal of all residual
thyroid tissue. Gross examination of the removed tissue confirmed that the capsular
surface was free of adhesion from surrounding structures. Microscopic examination
revealed a focus of papillary microcarcinoma, which was poorly demarcated and
measured 0.2 x 0.12 cm. The surgical margin was negative at 0.1 cm. Calcium levels
and parathyroid hormone levels on Day 388 (10 Jun 2009) were within normal limits.
The investigator judged this event as unrelated to study drug and the patient was treated
with vicodin and acetaminophen. The event of thyroid cancer was reported as resolved
on Day 388 (10 Jun 2009). The patient went on to complete the 2-year study period.
 
</item>
						</list>
					</text>
					<entry>
						<act classCode="CTTEVENT" moodCode="EVN">
							<id extension="ARM0001" root="2.1.3.7"/>
							<!-- ARMCD -->
							<code code="C99098" displayName="arm" codeSystem="2.16.840.1.113883.3.26.1.1" codeSystemName="NCI EVS" />
							<text>Arm Name</text>
						</act>
					</entry>
					<entry>
						<observation classCode="OBS" moodCode="EVN">
							<code code="xxxxx" displayName="Patient Narrative Report" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC"/>
							<value xsi:type="ED" mediaType="text/plain">This patient was a 50-year-old, White female. The patient’s first relapse was in
October 2007 (exact date not available). The patient’s Baseline score was 2.0.
Notable in this patient’s medical history were hypothyroidism, facial pain,
intervertebral disc degeneration, thyroid neoplasm, cervicobrachial syndrome,
breast mass, sinus polyp, tonsillectomy, and hypertension. The relevant
concomitant medications upon study entry were hydrochlorothiazide, acetylsalicylic acid,
and levothyroxine.
The last dose of study drug prior to the event was 23 May 2008. On Day 325 (08 Apr
2009), the patient was noted with grade 3 thyroid cancer (papillary thyroid
carcinoma) requiring surgical intervention. On the same day, the patient underwent right
thyroid lobectomy. The pathology report from the right thyroid lobectomy revealed a 4
cm follicular adenoma, as well as 2 incidental microscopic foci of papillary carcinoma
with the larger focus measuring 3.5 mm. The post-operative pathology examination
conducted on Day 327 (10 April 2009) revealed a microscopic papillary thyroid
carcinoma, confined by the thyroid capsule. The thyroid function tests performed on Day
337 (20 Apr 2009) were normal with the thyroid stimulating hormone (TSH) at 5.45
mU/L (normal 0.40 - 5.50 mU/L), Free T4 at 14.2 pmol/L (normal 10.3-23.2 pmol/L) and
Free T3 at 5.2 pmol/L (normal 3.5 - 6.5 pmol/L). On the same day, the patient was
advised to have the left side of her thyroid gland removed due to the carcinoma findings
on the right side, and several rounds of radiation treatment after surgery. The study drug
was permanently discontinued on Day 341 (24 Apr 2009) due to the event of thyroid
cancer and levothyroxine was started from Day 342 (25 Apr 2009). On Day 388
(10 June 2009), the patient underwent left thyroid lobectomy with removal of all residual
thyroid tissue. Gross examination of the removed tissue confirmed that the capsular
surface was free of adhesion from surrounding structures. Microscopic examination
revealed a focus of papillary microcarcinoma, which was poorly demarcated and
measured 0.2 x 0.12 cm. The surgical margin was negative at 0.1 cm. Calcium levels
and parathyroid hormone levels on Day 388 (10 Jun 2009) were within normal limits.
The investigator judged this event as unrelated to study drug and the patient was treated
with vicodin and acetaminophen. The event of thyroid cancer was reported as resolved
on Day 388 (10 Jun 2009). The patient went on to complete the 2-year study period.
•	</value>
						</observation>
					</entry>
				</section>
			</component>
		</structuredBody>
	</component>