Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously... | NCT00613626

NCT00613626

Status Module

Sponsor/Collaborators Module

Name	Class
AstraZeneca	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: ZD6474 Matched Placebo	Placebo Comparator	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.	Drug: Cisplatin Drug: Etoposide Drug: Placebo
Arm B: ZD6474	Active Comparator	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.	Drug: Cisplatin Drug: Etoposide Drug: ZD6474
Safety Lead-In	Experimental	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.	Drug: Cisplatin Drug: Etoposide Drug: ZD6474

Name	Type	Description	Arm Group Labels	Other Names
Cisplatin	Drug	Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles	Arm A: ZD6474 Matched Placebo Arm B: ZD6474 Safety Lead-In

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Disease Progression - Median Time to Progression and Log-Rank Test	Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.	24 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities	Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.	6 weeks (2 Cycles)
Measure the Response Rate (CR + PR) in Each Arm

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological or cytological proof of chemotherapy-naïve, extensive, small cell lung cancer.
Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy.
Written informed consent and HIPAA authorization for release of personal health information.
Age 18 years or older at the time of consent.
Potassium ≥4.0 mmol/L and <5.5mmol/L (supplementation is allowed).
Calcium within normal range (supplementation is allowed).
Magnesium within normal range (supplementation is allowed).

Exclusion Criteria:

No prior EGFR inhibitor or antiangiogenic agent allowed.
No prior hormonal therapy.
No symptomatic brain metastasis.
No clinically significant infections as judged by the treating investigator.
No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
No previous history of QTc prolongation as a result of medication that required discontinuation of that medication.
No congenital long QT syndrome or known 1st degree relative with unexplained sudden death under 40 years of age.
No presence of left bundle branch block (LBBB.)
No QTc with Bazett's correction that is unmeasurable, or ≥480 msec on screening ECG obtained within 7 days prior to registration for protocol therapy. If a subject has QTc ≥480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be <480 msec in order for the subject to be eligible for the study.
No concomitant (within 14 days prior to registration for and during protocol therapy) medication associated with Torsades de Pointes or cause QTc prolongation, is allowed. Medications that prolong QT, but are not strictly associated with Torsades, are allowed if medically necessary and will require increased ECG and electrolyte monitoring.
No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg).
No currently active diarrhea that may affect the ability to absorb ZD6474.
No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the subject has been disease-free for at least 5 years.
Major surgery must be completed greater than 28 days prior to registration for protocol therapy and healed surgical incision is required.
No concomitant (within 14 days prior to registration for and during protocol therapy) medications that are potent inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort) of CYP3A4 function.
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
Females must not be breastfeeding.

Contacts/Locations Module

Name	Affiliation	Role
Nasser Hanna, M.D.	Hoosier Oncology Group, Inc.	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Helen F. Graham Cancer Center		Newark	Delaware	19713	United States
Northwestern University Feinberg School of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Rachel E. Sanborn, Jyoti D. Patel, Gregory A. Masters, Nagesh Jayaram, Anthony W. Stephens, Michael J. Guarino, Jamal Ghazi Misleh, Corinne E. Williams, Jingwei Wu, Nasser H. Hanna. A randomized double-blind phase II trial of platinum (P) plus etoposide (E) with or without concurrent ZD6474 (Z) in patients (pts) with previously untreated extensive-stage (ES) small cell lung cancer (SCLC): Hoosier Oncology Group LUN06-113. J Clin Oncol 32:5s, 2014 (suppl; abstr 7506)

Label	URL
Hoosier Oncology Group Home Page	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG0027 subjectsThese participants provided the toxicity data to determine if ZD6474+Etopiside+Cisplatin was safe.

Subjects 18 years of age or older at time of consent, ECOG Performance Status of 0-1 14 days prior to registration, and histological or cytological proof of chemotherapy naive extensive small cell cancers or neuroendocrine cancers that are high grade or poorly differentiated.

Arm/Group Information

ID	Title	Description
BG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily
BG001	Arm B: ZD6474	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
BG002	Safety Lead-In	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.58± 10.92 BG00163.80± 5.90 BG00266.14± 3.34 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG00114 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00033 BG00133 BG002

ECOG Performance Status

Eastern Cooperative Oncology Group Score

0 Fully active, able to carry on all pre-disease performance without restriction

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
Dead

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG00012 BG001

Liver Metastases

Number

participants

Title

Denominators

Categories

Present

Title	Measurements
	BG00016 BG00113 BG002

Brain Metastases

Number

participants

Title

Denominators

Categories

Present

Title	Measurements
	BG00010 BG00110 BG002

Platinum Therapy

Number

participants

Title

Denominators

Categories

Cisplatin

Title	Measurements
	BG00017 BG00117 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Disease Progression - Median Time to Progression and Log-Rank Test

Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test. Safety lead-in participants are not included in this analysis per protocol.

Two participants from Arm A and Two Participants from Arm B were inevaluable for the time to disease progression analysis. (Reasons inevaluable include: toxicity and withdrawal of consent)

Posted

Median

95% Confidence Interval

Months

24 months

ID	Title	Description
OG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily
OG001	Arm B: ZD6474	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.

Units	Counts
Participants	OG00031 OG00131

Title

Denominators

Categories

Title	Measurements
	OG0005.68(3.98 to 6.41) OG0015.62(5.09 to 6.24)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A one-sided log rank test with an overall sample size of 68 subjects (of which 34 are in arm A and 34 are in arm B) achieves 80% power at a 0.10 significance level to detect a difference of 3 months in PFS between 4 month median PFS and 7 month median PFS.	Log Rank		0.10		Median Difference (Final Values)	3	Standard Error of the Mean	22.718	1-Sided	90							Superiority or Other (legacy)

Secondary

Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities

Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities. Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.

The participants from the safety run-in cohort were combined with the participants from ARM B for analysis of safety.

Posted

Number

percentage of participants

6 weeks (2 Cycles)

ID	Title	Description
OG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily
OG001	Arm B: ZD6474 + Safety Lead-In	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.

Secondary

Measure the Response Rate (CR + PR) in Each Arm

12 participants are excluded due to missing data.

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily
OG001	Arm B: ZD6474	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.

Secondary

Measure Disease Control Rate (CR + PR+ SD) in Each Arm

Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000). Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as: neither a partial response or progressive disease ( >=20% increase in the sum of the longest diameter of the target lesions).

12 participants were not analyzed due to missing data.

Posted

Number

95% Confidence Interval

percentage of participants

24 months

ID	Title	Description
OG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily
OG001	Arm B: ZD6474	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.

Secondary

Measure Overall Survival for Each Arm

Posted

Median

95% Confidence Interval

Months

24 months

ID	Title	Description
OG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily
OG001	Arm B: ZD6474	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.

Units	Counts

Secondary

Assess VEGF Polymorphisms and Correlate Subject Response

This data was not collected for the safety lead-in participants.

Posted

Number

probability

24 months

ID	Title	Description
OG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily
OG001	Arm B: ZD6474	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: ZD6474 Matched Placebo	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles Placebo: Matched placebo oral daily			8	33	32	33
EG001	Arm B: ZD6474	Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study.			14	41	39	41

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CARDIAC GENERAL - OTHER (SPECIFY, __)	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
CARDIAC ISCHEMIA/INFARCTION	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
CONFUSION	Nervous system disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
CONSTIPATION	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
DIARRHEA	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
DYSPNEA (SHORTNESS OF BREATH)	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
HEMOGLOBIN	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
HEMORRHAGE, GI / LOWER GI NOS	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / BRONCHOPULMONARY NOS	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / LUNG	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected41 at risk
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / ARTERY	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / BLADDER (URINARY)	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
INFECTION - OTHER (SPECIFY, __)	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
INFECTION WITH UNKNOWN ANC / MEDIASTINUM NOS	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
NAUSEA	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events1 affected41 at risk
NEUTROPHILS/GRANULOCYTES (ANC/AGC)	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
PAIN / ABDOMEN NOS	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
PAIN / BACK	General disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
PANCREATITIS	Hepatobiliary disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
PLATELETS	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected41 at risk
PNEUMONITIS/PULMONARY INFILTRATES	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0002 events1 affected33 at risk EG0010 events0 affected41 at risk
SODIUM, SERUM-LOW (HYPONATREMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FLUTTER	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
THROMBOSIS/THROMBUS/EMBOLISM	Vascular disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
VOMITING	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0009 events5 affected33 at risk EG0015 events5 affected41 at risk
ALKALINE PHOSPHATASE	Investigations	CTCAEv3	Non-systematic Assessment	EG0005 events5 affected33 at risk EG0015 events4 affected41 at risk
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)	Immune system disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected41 at risk
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)	Investigations	CTCAEv3	Non-systematic Assessment	EG0004 events3 affected33 at risk EG0012 events2 affected41 at risk
ANOREXIA	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG00012 events11 affected33 at risk EG00114 events13 affected41 at risk
ARTHRITIS (NON-SEPTIC)	Musculoskeletal and connective tissue disorders	CTCAEv3	Non-systematic Assessment	EG0006 events6 affected33 at risk EG0011 events1 affected41 at risk
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)	Investigations	CTCAEv3	Non-systematic Assessment	EG0004 events3 affected33 at risk EG0011 events1 affected41 at risk
BRONCHOSPASM, WHEEZING	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
CALCIUM, SERUM-HIGH (HYPERCALCEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
CALCIUM, SERUM-LOW (HYPOCALCEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0006 events3 affected33 at risk EG0019 events6 affected41 at risk
CARDIAC ISCHEMIA/INFARCTION	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0004 events4 affected33 at risk EG0012 events2 affected41 at risk
CONFUSION	Nervous system disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
CONSTIPATION	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG00012 events9 affected33 at risk EG00111 events9 affected41 at risk
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)	General disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events1 affected41 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG00021 events19 affected33 at risk EG00113 events12 affected41 at risk
CREATININE	Investigations	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0017 events7 affected41 at risk
CYSTITIS	Renal and urinary disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
DEHYDRATION	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0016 events4 affected41 at risk
DENTAL: TEETH	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
DIARRHEA	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG00110 events9 affected41 at risk
DIZZINESS	Nervous system disorders	CTCAEv3	Non-systematic Assessment	EG0008 events2 affected33 at risk EG0015 events5 affected41 at risk
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0013 events3 affected41 at risk
DYSPHAGIA (DIFFICULTY SWALLOWING)	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected41 at risk
DYSPNEA (SHORTNESS OF BREATH)	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG00022 events18 affected33 at risk EG00121 events19 affected41 at risk
EDEMA: HEAD AND NECK	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0011 events1 affected41 at risk
EDEMA: LIMB	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG00012 events8 affected33 at risk EG0012 events2 affected41 at risk
FATIGUE (ASTHENIA, LETHARGY, MALAISE)	General disorders	CTCAEv3	Non-systematic Assessment	EG00033 events24 affected33 at risk EG00136 events26 affected41 at risk
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)	General disorders	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0012 events2 affected41 at risk
FLATULENCE	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
FLUSHING	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
GLAUCOMA	Eye disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
GLOMERULAR FILTRATION RATE	Investigations	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG00012 events10 affected33 at risk EG00113 events9 affected41 at risk
GLUCOSE, SERUM-LOW (HYPOGLYCEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
HAIR LOSS/ALOPECIA (SCALP OR BODY)	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG00013 events10 affected33 at risk EG00115 events12 affected41 at risk
HEARING: PATIENTS WITHOUT BASELINE AUDIOGRAM AND NOT ENROLLED IN A MONITORING PROGRAM	Ear and labyrinth disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected41 at risk
HEARTBURN/DYSPEPSIA	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0016 events6 affected41 at risk
HEMOGLOBIN	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG00031 events16 affected33 at risk EG00124 events14 affected41 at risk
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected41 at risk
HEMORRHAGE, GI / UPPER GI NOS	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / RESPIRATORY TRACT NOS	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
HICCOUGHS (HICCUPS, SINGULTUS)	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected41 at risk
HOT FLASHES/FLUSHES	Endocrine disorders	CTCAEv3	Non-systematic Assessment	EG0002 events1 affected33 at risk EG0010 events0 affected41 at risk
HYPERTENSION	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0006 events6 affected33 at risk EG00116 events10 affected41 at risk
HYPOTENSION	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / MUCOSA	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
INFECTIONWITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / PHARYNX	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
INFECTION - OTHER (SPECIFY, __)	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / UPPER AIRWAY NOS	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
INFECTION WITH UNKNOWN ANC / WOUND	Infections and infestations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
INSOMNIA	General disorders	CTCAEv3	Non-systematic Assessment	EG0006 events6 affected33 at risk EG0016 events6 affected41 at risk
LEUKOCYTES (TOTAL WBC)	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG00011 events7 affected33 at risk EG00120 events12 affected41 at risk
LIPASE	Investigations	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG0004 events3 affected33 at risk EG0012 events2 affected41 at risk
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG00011 events7 affected33 at risk EG00116 events12 affected41 at risk
MEMORY IMPAIRMENT	Nervous system disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
METABOLIC/LABORATORY - OTHER (SPECIFY, __)	Investigations	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
MOOD ALTERATION / AGITATION	Psychiatric disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
MOOD ALTERATION / ANXIETY	Psychiatric disorders	CTCAEv3	Non-systematic Assessment	EG0007 events7 affected33 at risk EG0015 events5 affected41 at risk
MOOD ALTERATION / DEPRESSION	Psychiatric disorders	CTCAEv3	Non-systematic Assessment	EG0004 events4 affected33 at risk EG0014 events4 affected41 at risk
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY	Surgical and medical procedures	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0018 events7 affected41 at risk
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected41 at risk
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTRAOCULAR	Eye disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected41 at risk
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED	Musculoskeletal and connective tissue disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)	Musculoskeletal and connective tissue disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected41 at risk
NAUSEA	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG00018 events14 affected33 at risk EG00117 events16 affected41 at risk
NEUROENDOCRINE: ADH SECRETION ABNORMALITY (E.G., SIADH OR LOW ADH)	Endocrine disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
NEUROPATHY: CRANIAL / CN V MOTOR-JAW MUSCLES; SENSORY-FACIAL	Nervous system disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
NEUROPATHY: MOTOR	Nervous system disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
NEUROPATHY: SENSORY	Nervous system disorders	CTCAEv3	Non-systematic Assessment	EG0004 events4 affected33 at risk EG0014 events4 affected41 at risk
NEUTROPHILS/GRANULOCYTES (ANC/AGC)	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG00017 events11 affected33 at risk EG00126 events19 affected41 at risk
OPHTHALMOPLEGIA/DIPLOPIA (DOUBLE VISION)	Eye disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
OTITIS, MIDDLE EAR (NON-INFECTIOUS)	Ear and labyrinth disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
PAIN / ABDOMEN NOS	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0004 events4 affected33 at risk EG0012 events2 affected41 at risk
PAIN / BACK	General disorders	CTCAEv3	Non-systematic Assessment	EG00010 events10 affected33 at risk EG0018 events8 affected41 at risk
PAIN / BONE	Musculoskeletal and connective tissue disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
PAIN / BUTTOCK	General disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
PAIN / CARDIAC/HEART	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
PAIN / CHEST WALL	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0006 events5 affected33 at risk EG0014 events4 affected41 at risk
PAIN / CHEST/THORAX NOS	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0017 events6 affected41 at risk
PAIN / DENTAL/TEETH/PERIDONTAL	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
PAIN / EXTREMITY-LIMB	Musculoskeletal and connective tissue disorders	CTCAEv3	Non-systematic Assessment	EG0004 events3 affected33 at risk EG0015 events4 affected41 at risk
PAIN / FACE	General disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
PAIN / HEAD/HEADACHE	General disorders	CTCAEv3	Non-systematic Assessment	EG0006 events6 affected33 at risk EG0017 events5 affected41 at risk
PAIN / JOINT	Musculoskeletal and connective tissue disorders	CTCAEv3	Non-systematic Assessment	EG0004 events4 affected33 at risk EG0013 events3 affected41 at risk
PAIN / MUSCLE	Musculoskeletal and connective tissue disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
PAIN / NECK	General disorders	CTCAEv3	Non-systematic Assessment	EG0004 events4 affected33 at risk EG0011 events1 affected41 at risk
PAIN / ORAL CAVITY	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
PAIN / PAIN NOS	General disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
PAIN / PLEURA	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
PAIN / STOMACH	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
PAIN / THROAT/PHARYNX/LARYNX	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
PAIN - OTHER (SPECIFY, __)	General disorders	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0010 events0 affected41 at risk
PALPITATIONS	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0013 events3 affected41 at risk
PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE	Endocrine disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected41 at risk
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0014 events4 affected41 at risk
PLATELETS	Blood and lymphatic system disorders	CTCAEv3	Non-systematic Assessment	EG0009 events5 affected33 at risk EG00111 events10 affected41 at risk
PLEURAL EFFUSION (NON-MALIGNANT)	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
PNEUMONITIS/PULMONARY INFILTRATES	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
POTASSIUM, SERUM-HIGH (HYPERKALEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0014 events4 affected41 at risk
POTASSIUM, SERUM-LOW (HYPOKALEMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG00010 events5 affected33 at risk EG0017 events6 affected41 at risk
PROLONGED QTC INTERVAL	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
PRURITUS/ITCHING	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG0003 events3 affected33 at risk EG0012 events2 affected41 at risk
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
RASH/DESQUAMATION	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG0003 events2 affected33 at risk EG00110 events8 affected41 at risk
RASH: ACNE/ACNEIFORM	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
RASH: DERMATITIS ASSOCIATED WITH RADIATION / CHEMORADIATION	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0013 events1 affected41 at risk
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)	Skin and subcutaneous tissue disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
RIGORS/CHILLS	General disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
SODIUM, SERUM-HIGH (HYPERNATREMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0012 events2 affected41 at risk
SODIUM, SERUM-LOW (HYPONATREMIA)	Investigations	CTCAEv3	Non-systematic Assessment	EG0009 events8 affected33 at risk EG00111 events9 affected41 at risk
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS BRADYCARDIA	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA	Cardiac disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
SWEATING (DIAPHORESIS)	General disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected41 at risk
TASTE ALTERATION (DYSGEUSIA)	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected41 at risk
THROMBOSIS/THROMBUS/EMBOLISM	Vascular disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0011 events1 affected41 at risk
THYROID FUNCTION, LOW (HYPOTHYROIDISM)	Endocrine disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0012 events2 affected41 at risk
TINNITUS	Ear and labyrinth disorders	CTCAEv3	Non-systematic Assessment	EG0005 events5 affected33 at risk EG0011 events1 affected41 at risk
ULCER, GI / STOMA	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
URINARY FREQUENCY/URGENCY	Renal and urinary disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0012 events2 affected41 at risk
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)	Renal and urinary disorders	CTCAEv3	Non-systematic Assessment	EG0001 events1 affected33 at risk EG0010 events0 affected41 at risk
VAGINAL DRYNESS	Reproductive system and breast disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0011 events1 affected41 at risk
VISION-BLURRED VISION	Eye disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0011 events1 affected41 at risk
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)	Respiratory, thoracic and mediastinal disorders	CTCAEv3	Non-systematic Assessment	EG0000 events0 affected33 at risk EG0013 events3 affected41 at risk
VOMITING	Gastrointestinal disorders	CTCAEv3	Non-systematic Assessment	EG0005 events4 affected33 at risk EG0016 events6 affected41 at risk
WEIGHT GAIN	General disorders	CTCAEv3	Non-systematic Assessment	EG0002 events2 affected33 at risk EG0010 events0 affected41 at risk
WEIGHT LOSS	General disorders	CTCAEv3	Non-systematic Assessment	EG0003 events2 affected33 at risk EG00111 events9 affected41 at risk

The primary object analysis was under powered. The sample size calculation determined 34 subjects per arm, however the actual primary objective analysis was based on 31 subjects per arm.

Certain Agreements

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D002945	Cisplatin
D005047	Etoposide
C452423	vandetanib

Ancestor Terms

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates