Study Evaluating Interferon And CCI-779 In Advanced Renal... | NCT00065468

NCT00065468

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Intervention Names
A	Active Comparator	Drug: Interferon Alfa
B	Experimental	Drug: CCI-779
C	Experimental	Drug: Interferon Alfa and CCI-779

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon Alfa	Drug	Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.	Baseline up to Month 80

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)	PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.	Baseline, monthly until tumor progression or death (up to Month 80)
Percentage of Participants With Objective Response

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Little Rock	Arkansas	72205	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37146227	Derived	Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
28410911

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
FG001	Temsirolimus

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
BG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
BG002	Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
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
	OG0007.3(6.1 to 8.8) OG00110.9(8.6 to 12.7) OG0028.4(6.6 to 10.3)

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		Log Rank	Stratified by prior nephrectomy and region	0.0252		Cox Proportional Hazard	0.78			2-Sided	95	0.63	0.97				Yes	Non-Inferiority or Equivalence	2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.

Secondary

Progression-Free Survival (PFS)

PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.

ITT

Posted

Median

95% Confidence Interval

months

Baseline, monthly until tumor progression or death (up to Month 80)

ID	Title	Description
OG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
OG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
OG002	Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Units

Secondary

Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

ITT

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, every 2 months until tumor progression or death (up to Month 80)

ID	Title	Description
OG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
OG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
OG002	Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Secondary

Percentage of Participants With Clinical Benefit

Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

ITT

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, every 2 months until tumor progression or death (up to Month 80)

ID	Title	Description
OG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
OG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
OG002	Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Secondary

Duration of Response (DR)

DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.

ITT subset of participants who had a response

Posted

Median

95% Confidence Interval

months

Baseline, every month until tumor progression or death (up to Month 80)

ID	Title	Description
OG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
OG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
OG002	Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Secondary

Time to Treatment Failure (TTF)

TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.

ITT

Posted

Median

95% Confidence Interval

months

Baseline, every month until tumor progression or death (up to Month 80)

ID	Title	Description
OG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
OG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
OG002	Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Secondary

Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)

The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the "dispersion" of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.

ITT

Posted

Number

months

Baseline to Month 80

ID	Title	Description
OG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
OG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal

Secondary

European Quality of Life Health Questionnaire (EQ-5D) - Index Score

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.

ITT;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.

Posted

Median

Full Range

units on a scale

Baseline

ID	Title	Description
OG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
OG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
OG002	Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Interferon Alfa	Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal	99	200	197	200
EG001	Temsirolimus	Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal	82	208	208	208
EG002	Interferon Alfa and Temsirolimus	Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal	122	208	205	208

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ABDOMINAL PAIN	General disorders	COSTART	Non-systematic Assessment	Body as a whole	EG0001 affected200 at risk EG0015 affected208 at risk EG0024 affected208 at risk
BACK PAIN	General disorders	COSTART	Non-systematic Assessment		EG0002 affected200 at risk EG0014 affected208 at risk EG0021 affected208 at risk
CARCINOMA	General disorders	COSTART	Non-systematic Assessment		EG0009 affected200 at risk EG0014 affected208 at risk EG00213 affected208 at risk
ASTHENIA	General disorders	COSTART	Non-systematic Assessment		EG0007 affected200 at risk EG0013 affected208 at risk EG00210 affected208 at risk
FEVER	General disorders	COSTART	Non-systematic Assessment		EG0003 affected200 at risk EG0013 affected208 at risk EG0028 affected208 at risk
ASCITES	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0012 affected208 at risk EG0020 affected208 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0012 affected208 at risk EG0021 affected208 at risk
PAIN	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0012 affected208 at risk EG0023 affected208 at risk
ABSCESS	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
ACCIDENTAL INJURY	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0023 affected208 at risk
CHEST PAIN	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
HERNIA	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
INFECTION	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
INFLAMMATION	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
MALAISE	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
MEDICATION ERROR	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
NEOPLASM	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
OVERDOSE	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0022 affected208 at risk
PELVIC PAIN	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
SEPSIS	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0023 affected208 at risk
ABDOMINAL SYNDROME ACUTE	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
ACCIDENTAL OVERDOSE	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
ALLERGIC REACTION	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CELLULITIS	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0023 affected208 at risk
CHILLS	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
FLU SYNDROME	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
GENERALIZED EDEMA	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
NECK PAIN	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0022 affected208 at risk
TUMOR LYSIS SYNDROME	General disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
ATRIAL FIBRILLATION	Cardiac disorders	COSTART	Non-systematic Assessment	Cardiovascular system	EG0002 affected200 at risk EG0012 affected208 at risk EG0021 affected208 at risk
CONGESTIVE HEART FAILURE	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0012 affected208 at risk EG0020 affected208 at risk
DEEP VEIN THROMBOSIS	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0012 affected208 at risk EG0020 affected208 at risk
HYPERTENSION	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0012 affected208 at risk EG0022 affected208 at risk
MYOCARDIAL INFARCT	Cardiac disorders	COSTART	Non-systematic Assessment		EG0002 affected200 at risk EG0012 affected208 at risk EG0021 affected208 at risk
PULMONARY EMBOLUS	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0012 affected208 at risk EG0023 affected208 at risk
CEREBROVASCULAR ACCIDENT	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
HEART FAILURE	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0022 affected208 at risk
INTRACRANIAL HEMORRHAGE 0	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
PERICARDIAL EFFUSION	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
PERIPHERAL GANGRENE	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
SYNCOPE	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
TACHYCARDIA SINUS	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
ANGINA PECTORIS	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CARDIOMYOPATHY	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CEREBRAL HEMORRHAGE	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CEREBRAL ISCHEMIA	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CEREBROVASCULAR DISORDER	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
HEART ARREST	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
HEMORRHAGE	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0022 affected208 at risk
HYPOTENSION	Cardiac disorders	COSTART	Non-systematic Assessment		EG0002 affected200 at risk EG0010 affected208 at risk EG0022 affected208 at risk
HYPOVOLEMIA	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
POSTURAL HYPOTENSION 1	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
SHOCK	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
THROMBOSIS	Cardiac disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
VASCULAR DISORDER	Cardiac disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
STOMATITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment	Digestive System	EG0000 affected200 at risk EG0013 affected208 at risk EG0024 affected208 at risk
GASTROINTESTINAL HEMORRHAGE	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0012 affected208 at risk EG0020 affected208 at risk
NAUSEA	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0003 affected200 at risk EG0012 affected208 at risk EG0022 affected208 at risk
VOMITING	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0003 affected200 at risk EG0012 affected208 at risk EG0021 affected208 at risk
DIARRHEA	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0026 affected208 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
ILEUS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
MUCOSITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0022 affected208 at risk
ANOREXIA	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0023 affected208 at risk
COLITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CONSTIPATION	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
GASTROENTERITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
HEMATEMESIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
HEMORRHAGIC GASTRITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
HEPATIC FAILURE	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
HEPATITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
LIVER FATTY DEPOSIT	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
MELENA	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
PROCTITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
RECTAL HEMORRHAGE	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
DIABETES MELLITUS	Endocrine disorders	COSTART	Non-systematic Assessment	Endocrine system	EG0000 affected200 at risk EG0012 affected208 at risk EG0020 affected208 at risk
THYROID CARCINOMA	Endocrine disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
ANEMIA	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment	Hemic and Lymphatic system	EG00012 affected200 at risk EG00111 affected208 at risk EG00220 affected208 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0024 affected208 at risk
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
FIBRINOGEN INCREASED	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
THROMBIN TIME PROLONGED	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
HYPERGLYCEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment	Metabolic and Nutritional	EG0000 affected200 at risk EG0016 affected208 at risk EG0020 affected208 at risk
DEHYDRATION	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0007 affected200 at risk EG0015 affected208 at risk EG00210 affected208 at risk
CREATININE INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0013 affected208 at risk EG0021 affected208 at risk
HYPERCALCEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0002 affected200 at risk EG0013 affected208 at risk EG0024 affected208 at risk
HYPERKALEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0002 affected200 at risk EG0012 affected208 at risk EG0022 affected208 at risk
ALKALINE PHOSPHATASE INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
BUN INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
HYPERLIPEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0023 affected208 at risk
HYPOCALCEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0022 affected208 at risk
HYPOKALEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
HYPONATREMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
PERIPHERAL EDEMA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
SGOT INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
BILIRUBINEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
CACHEXIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0022 affected208 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
HYPOGLYCEMIAHYPOGLYCEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
HYPOPROTEINEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
KETOSIS	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
WEIGHT LOSS	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment	Musculoskeletal system	EG0000 affected200 at risk EG0012 affected208 at risk EG0021 affected208 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
SPINAL FRACTURE	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
BONE DISORDER	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
OSTEOPOROSIS FRACTURE	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
CONFUSION	Nervous system disorders	COSTART	Non-systematic Assessment	Nervous system	EG0003 affected200 at risk EG0013 affected208 at risk EG0020 affected208 at risk
DIZZINESS	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
HYPOTONIA	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
PARESIS	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
AGITATION	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
AMNESIA	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
APHASIA	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CNS DEPRESSION	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CNS NEOPLASIA	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
COMA	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
CONVULSION	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
DELIRIUM	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
DEPRESSION	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
DYSTONIA	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
EXTRAPYRAMIDAL SYNDROME	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
GRAND MAL CONVULSION	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
HYPESTHESIA	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
INSOMNIA	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
MENTAL STATUS CHANGES	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
NEUROPATHY	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
PARALYSIS	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
PARKINSON'S DISEASE	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
PSYCHOSIS	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
SOMNOLENCE	Nervous system disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
SUICIDAL IDEATION	Nervous system disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
PNEUMONIA	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment	Respiratory system	EG0003 affected200 at risk EG00110 affected208 at risk EG00211 affected208 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0004 affected200 at risk EG0016 affected208 at risk EG0024 affected208 at risk
DYSPNEA	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0009 affected200 at risk EG0012 affected208 at risk EG00215 affected208 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0012 affected208 at risk EG0020 affected208 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0003 affected200 at risk EG0012 affected208 at risk EG0023 affected208 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
BRONCHITIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0022 affected208 at risk
CARCINOMA OF LUNG	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
HEMOTHORAX	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
PHARYNGITIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0021 affected208 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
BRONCHIOLITIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
COUGH INCREASED	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
HEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
LUNG EDEMA	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
LUNG FIBROSIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
LUNG INFILTRATION NOS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
RESPIRATORY DISORDER	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
SKIN CARCINOMA	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment	Skin and Appendages	EG0000 affected200 at risk EG0010 affected208 at risk EG0022 affected208 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
CATARACT SPECIFIED	Eye disorders	COSTART	Non-systematic Assessment	Special senses	EG0000 affected200 at risk EG0010 affected208 at risk EG0022 affected208 at risk
DIPLOPIA	Eye disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
ACUTE KIDNEY FAILURE	Renal and urinary disorders	COSTART	Non-systematic Assessment	Urogenital system	EG0006 affected200 at risk EG0013 affected208 at risk EG0024 affected208 at risk
GLOMERULITIS	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
KIDNEY FAILURE	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0011 affected208 at risk EG0023 affected208 at risk
UREMIA	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
URINARY TRACT INFECTION	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0011 affected208 at risk EG0020 affected208 at risk
HEMATURIA	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0003 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
KIDNEY FUNCTION ABNORMAL	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0023 affected208 at risk
OLIGURIA	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
URINARY INCONTINENCE	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0022 affected208 at risk
URINARY RETENTION	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0000 affected200 at risk EG0010 affected208 at risk EG0021 affected208 at risk
URINARY TRACT DISORDER	Renal and urinary disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG0010 affected208 at risk EG0020 affected208 at risk
DEVICE MALFUNCTION	General disorders	COSTART	Non-systematic Assessment	Adverse event associated with miscellaneous factors	EG0000 affected200 at risk EG0010 affected208 at risk EG0022 affected208 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ASTHENIA	General disorders	COSTART	Non-systematic Assessment	Body as a whole	EG000126 affected200 at risk EG001105 affected208 at risk EG002127 affected208 at risk
PAIN	General disorders	COSTART	Non-systematic Assessment		EG00030 affected200 at risk EG00156 affected208 at risk EG00241 affected208 at risk
FEVER	General disorders	COSTART	Non-systematic Assessment		EG00098 affected200 at risk EG00149 affected208 at risk EG002126 affected208 at risk
ABDOMINAL PAIN	General disorders	COSTART	Non-systematic Assessment		EG00034 affected200 at risk EG00142 affected208 at risk EG00234 affected208 at risk
BACK PAIN	General disorders	COSTART	Non-systematic Assessment		EG00028 affected200 at risk EG00141 affected208 at risk EG00231 affected208 at risk
CHEST PAIN	General disorders	COSTART	Non-systematic Assessment		EG00018 affected200 at risk EG00135 affected208 at risk EG00223 affected208 at risk
HEADACHE	General disorders	COSTART	Non-systematic Assessment		EG00030 affected200 at risk EG00132 affected208 at risk EG00247 affected208 at risk
INFECTION	General disorders	COSTART	Non-systematic Assessment		EG00011 affected200 at risk EG00129 affected208 at risk EG00232 affected208 at risk
ALLERGIC REACTION	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG00118 affected208 at risk EG00211 affected208 at risk
CHILLS	General disorders	COSTART	Non-systematic Assessment		EG00058 affected200 at risk EG00117 affected208 at risk EG00272 affected208 at risk
FACE EDEMA	General disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG00115 affected208 at risk EG00210 affected208 at risk
ACCIDENTAL INJURY	General disorders	COSTART	Non-systematic Assessment		EG0008 affected200 at risk EG00113 affected208 at risk EG00212 affected208 at risk
FLU SYNDROME	General disorders	COSTART	Non-systematic Assessment		EG00023 affected200 at risk EG0018 affected208 at risk EG00228 affected208 at risk
LAB TEST ABNORMAL	General disorders	COSTART	Non-systematic Assessment		EG0005 affected200 at risk EG0018 affected208 at risk EG00213 affected208 at risk
HYPERTENSION	Cardiac disorders	COSTART	Non-systematic Assessment	Cardiovascular system	EG0007 affected200 at risk EG00112 affected208 at risk EG00212 affected208 at risk
HYPOTENSION	Cardiac disorders	COSTART	Non-systematic Assessment		EG00011 affected200 at risk EG00110 affected208 at risk EG0027 affected208 at risk
TACHYCARDIA	Cardiac disorders	COSTART	Non-systematic Assessment		EG00011 affected200 at risk EG0019 affected208 at risk EG00217 affected208 at risk
VASODILATATION	Cardiac disorders	COSTART	Non-systematic Assessment		EG0005 affected200 at risk EG0015 affected208 at risk EG00212 affected208 at risk
NAUSEA	Gastrointestinal disorders	COSTART	Non-systematic Assessment	Digestive system	EG00082 affected200 at risk EG00176 affected208 at risk EG00284 affected208 at risk
ANOREXIA	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG00086 affected200 at risk EG00166 affected208 at risk EG00279 affected208 at risk
DIARRHEA	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG00039 affected200 at risk EG00157 affected208 at risk EG00256 affected208 at risk
CONSTIPATION	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG00035 affected200 at risk EG00142 affected208 at risk EG00239 affected208 at risk
STOMATITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0007 affected200 at risk EG00141 affected208 at risk EG00242 affected208 at risk
MUCOSITIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG00010 affected200 at risk EG00139 affected208 at risk EG00246 affected208 at risk
VOMITING	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG00057 affected200 at risk EG00139 affected208 at risk EG00260 affected208 at risk
DRY MOUTH	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG00016 affected200 at risk EG00113 affected208 at risk EG00212 affected208 at risk
MOUTH ULCERATION	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0005 affected200 at risk EG0016 affected208 at risk EG00215 affected208 at risk
ORAL MONILIASIS	Gastrointestinal disorders	COSTART	Non-systematic Assessment		EG0004 affected200 at risk EG0015 affected208 at risk EG00215 affected208 at risk
ANEMIA	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment	Hemic and Lymphatic system	EG00078 affected200 at risk EG00190 affected208 at risk EG002123 affected208 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG00016 affected200 at risk EG00128 affected208 at risk EG00277 affected208 at risk
NEUTROPENIA	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG00026 affected200 at risk EG00115 affected208 at risk EG00257 affected208 at risk
LEUKOPENIA	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG00034 affected200 at risk EG00113 affected208 at risk EG00265 affected208 at risk
LYMPHOPENIA	Blood and lymphatic system disorders	COSTART	Non-systematic Assessment		EG00017 affected200 at risk EG00111 affected208 at risk EG00228 affected208 at risk
HYPERLIPEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment	Metabolic and Nutritional	EG00029 affected200 at risk EG00157 affected208 at risk EG00280 affected208 at risk
PERIPHERAL EDEMA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00015 affected200 at risk EG00154 affected208 at risk EG00236 affected208 at risk
HYPERCHOLESTEREMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0009 affected200 at risk EG00151 affected208 at risk EG00255 affected208 at risk
HYPERGLYCEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00022 affected200 at risk EG00149 affected208 at risk EG00236 affected208 at risk
WEIGHT LOSS	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00049 affected200 at risk EG00140 affected208 at risk EG00265 affected208 at risk
CREATININE INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00021 affected200 at risk EG00128 affected208 at risk EG00242 affected208 at risk
ALKALINE PHOSPHATASE INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00015 affected200 at risk EG00120 affected208 at risk EG00231 affected208 at risk
HYPOKALEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0007 affected200 at risk EG00120 affected208 at risk EG00214 affected208 at risk
EDEMA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0008 affected200 at risk EG00119 affected208 at risk EG0028 affected208 at risk
HYPOPHOSPHATEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0004 affected200 at risk EG00117 affected208 at risk EG00221 affected208 at risk
SGOT INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00029 affected200 at risk EG00116 affected208 at risk EG00243 affected208 at risk
HYPOPROTEINEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00018 affected200 at risk EG00113 affected208 at risk EG00221 affected208 at risk
LACTIC DEHYDROGENASE INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0007 affected200 at risk EG00112 affected208 at risk EG00219 affected208 at risk
SGPT INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00014 affected200 at risk EG00112 affected208 at risk EG00215 affected208 at risk
HYPOCALCEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00021 affected200 at risk EG00111 affected208 at risk EG00232 affected208 at risk
HYPERCALCEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00011 affected200 at risk EG0018 affected208 at risk EG0028 affected208 at risk
HYPERKALEMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00018 affected200 at risk EG0018 affected208 at risk EG00211 affected208 at risk
DEHYDRATION	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG00015 affected200 at risk EG0017 affected208 at risk EG00222 affected208 at risk
HYPONATREMIA	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0007 affected200 at risk EG0016 affected208 at risk EG00215 affected208 at risk
BUN INCREASED	Metabolism and nutrition disorders	COSTART	Non-systematic Assessment		EG0005 affected200 at risk EG0013 affected208 at risk EG00211 affected208 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment	Musculoskeletal system	EG00029 affected200 at risk EG00138 affected208 at risk EG00227 affected208 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment		EG00030 affected200 at risk EG00116 affected208 at risk EG00222 affected208 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	COSTART	Non-systematic Assessment		EG00011 affected200 at risk EG0018 affected208 at risk EG0027 affected208 at risk
INSOMNIA	Nervous system disorders	COSTART	Non-systematic Assessment	Nervous system	EG00029 affected200 at risk EG00125 affected208 at risk EG00236 affected208 at risk
DIZZINESS	Nervous system disorders	COSTART	Non-systematic Assessment		EG00025 affected200 at risk EG00118 affected208 at risk EG00227 affected208 at risk
ANXIETY	Nervous system disorders	COSTART	Non-systematic Assessment		EG00012 affected200 at risk EG00116 affected208 at risk EG00224 affected208 at risk
PARESTHESIA	Nervous system disorders	COSTART	Non-systematic Assessment		EG00010 affected200 at risk EG00114 affected208 at risk EG00213 affected208 at risk
SOMNOLENCE	Nervous system disorders	COSTART	Non-systematic Assessment		EG00021 affected200 at risk EG00114 affected208 at risk EG00214 affected208 at risk
DEPRESSION	Nervous system disorders	COSTART	Non-systematic Assessment		EG00026 affected200 at risk EG0019 affected208 at risk EG00225 affected208 at risk
CONFUSION	Nervous system disorders	COSTART	Non-systematic Assessment		EG00017 affected200 at risk EG0016 affected208 at risk EG00210 affected208 at risk
DYSPNEA	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment	Respiratory system	EG00042 affected200 at risk EG00159 affected208 at risk EG00251 affected208 at risk
COUGH INCREASED	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG00029 affected200 at risk EG00155 affected208 at risk EG00249 affected208 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0007 affected200 at risk EG00127 affected208 at risk EG00227 affected208 at risk
PHARYNGITIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0003 affected200 at risk EG00124 affected208 at risk EG00227 affected208 at risk
RHINITIS	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0004 affected200 at risk EG00120 affected208 at risk EG00210 affected208 at risk
UPPER RESPIRATORY INFECTION	Respiratory, thoracic and mediastinal disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG00114 affected208 at risk EG0027 affected208 at risk
RASH	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment	Skin and Appendages	EG00011 affected200 at risk EG00176 affected208 at risk EG00234 affected208 at risk
PRURITUS	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG00016 affected200 at risk EG00140 affected208 at risk EG00224 affected208 at risk
NAIL DISORDER	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG00128 affected208 at risk EG0025 affected208 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG00014 affected200 at risk EG00122 affected208 at risk EG00213 affected208 at risk
ACNE	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG0002 affected200 at risk EG00121 affected208 at risk EG0027 affected208 at risk
EXFOLIATIVE DERMATITIS	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG00116 affected208 at risk EG0026 affected208 at risk
PRURITIC RASH	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG00111 affected208 at risk EG0023 affected208 at risk
SKIN DISORDER	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG0001 affected200 at risk EG00111 affected208 at risk EG0026 affected208 at risk
SWEATING	Skin and subcutaneous tissue disorders	COSTART	Non-systematic Assessment		EG00014 affected200 at risk EG0015 affected208 at risk EG00215 affected208 at risk
TASTE PERVERSION	General disorders	COSTART	Non-systematic Assessment	Special Senses	EG00013 affected200 at risk EG00131 affected208 at risk EG00218 affected208 at risk
TASTE LOSS	General disorders	COSTART	Non-systematic Assessment	Special Senses	EG0004 affected200 at risk EG00111 affected208 at risk EG0025 affected208 at risk
URINARY TRACT INFECTION	Renal and urinary disorders	COSTART	Non-systematic Assessment	Urogenital system	EG00010 affected200 at risk EG00116 affected208 at risk EG00223 affected208 at risk

Certain Agreements

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

Ancestor Terms

ID	Term
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

ID	Term
D002292	Carcinoma, Renal Cell
D007680	Kidney Neoplasms