Paclitaxel Albumin-Stabilized Nanoparticle Formulation in... | NCT00609791

ID	Type	Description	Link
P30CA033572	U.S. NIH Grant/Contract		View source
CHNMC-07157
ABRAXIS-ABX206-BC07US
CDR0000586461	Registry Identifier	NCI PDQ
NCI-2011-02403	Registry Identifier	CTRP (Clinical Trial Reporting Program

Name	Class
National Cancer Institute (NCI)	NIH

Label	Type	Description	Intervention Names
nab-paclitaxel	Experimental		Drug: paclitaxel albumin-stabilized nanoparticle formulation Other: pharmacological study Other: physiologic testing Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: cognitive assessment Procedure: psychosocial assessment and care

Name	Type	Description	Arm Group Labels	Other Names
paclitaxel albumin-stabilized nanoparticle formulation	Drug	100 mg/m2 3 weeks on 1 week off	nab-paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Area Under the Curve Over 24 Hours (AUC24)	Mean of area under the curve over 24 hours (AUC24) reported as well as linear regression of AUC24 by age and chemotherapy toxicity risk score. Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19: patient age (>=72 years); creatinine clearance (<34 mL/min); presence of amenia (<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type	Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment
Mean Clearance (CL)	Mean CL reported as well as regression results of CL by age and chemotherapy toxicity risk score. Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19: patient age (>=72 years); creatinine clearance (<34 mL/min); presence of amenia (<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type	Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

Secondary Outcomes

Measure	Description	Time Frame
Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score	Comparison of presence of grade 3 toxicity rate by risk score distribution. Chemotherapy toxicity risk score is based on the following variables. Higher scores indicate more risk, range of 2-19: patient age (>=72 years); creatinine clearance (<34 mL/min); presence of amenia (<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type Chemotherapy toxicity risk score category: Low risk score - toxicity risk score: 0-5 Medium risk score - toxicity risk score: 6-9 High risk score - toxicity risk score: 10-19

Name	Affiliation	Role
Mina Sedrak, MD	City of Hope Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope Medical Center		Duarte	California	91010-3000	United States
City of Hope Medical Group

PubMed Identifier	Type	Citation	Retractions
25492923	Derived	Hurria A, Blanchard MS, Synold TW, Mortimer J, Chung CT, Luu T, Katheria V, Rotter AJ, Wong C, Choi A, Feng T, Ramani R, Doan CM, Brown J, Somlo G. Age-related changes in nanoparticle albumin-bound paclitaxel pharmacokinetics and pharmacodynamics: influence of chronological versus functional age. Oncologist. 2015 Jan;20(1):37-44. doi: 10.1634/theoncologist.2014-0202. Epub 2014 Dec 9.

ID	Title	Description
FG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 22, 2019

ID	Title	Description
BG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Units	Counts
Participants	BG00039

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

Mean Area Under the Curve Over 24 Hours (AUC24)

Mean of area under the curve over 24 hours (AUC24) reported as well as linear regression of AUC24 by age and chemotherapy toxicity risk score.

Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19:

patient age (>=72 years); creatinine clearance (<34 mL/min); presence of amenia (<10 g/dL); hearing impairment; falls in the last 6 months; need for assistance with taking medications; limitations in walking one block; decreased social activities; chemotherapy dosing; number of chemotherapy drugs; cancer type

Three participants did not have AUC data through 24 hours post treatment due to incomplete blood samples

Posted

Mean

Standard Deviation

µg/mL*hour

Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

ID	Title	Description
OG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Units	Counts
Participants	OG00036

Title

Denominators

Categories

Title	Measurements
	OG0004711± 2777

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	Linear regression of ln AUC24 on age in years	Regression, Linear		0.055		Slope	0.011	Standard Error of the Mean	0.0057	2-Sided								Superiority
OG000	Linear regression of ln AUC24 on chemotherapy toxicity risk score

Primary

Mean Clearance (CL)

Mean CL reported as well as regression results of CL by age and chemotherapy toxicity risk score.

Chemotherapy toxicity risk score is based on the following variables and the value assigned to them. Higher scores indicate more risk, range of 2-19:

Nine participants did not have CL data due to incomplete blood samples

Posted

Mean

Standard Deviation

L/h

Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post treatment

ID	Title	Description
OG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Secondary

Grade 3 Toxicity Rate by Chemotherapy Toxicity Risk Score

Comparison of presence of grade 3 toxicity rate by risk score distribution.

Chemotherapy toxicity risk score is based on the following variables. Higher scores indicate more risk, range of 2-19:

Chemotherapy toxicity risk score category:

Low risk score - toxicity risk score: 0-5 Medium risk score - toxicity risk score: 6-9 High risk score - toxicity risk score: 10-19

Posted

Count of Participants

Participants

Up to 2.5 years

ID	Title	Description
OG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Secondary

Best Response

Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Posted

Count of Participants

Participants

Assessed after every 2 cycles of therapy until progression, up to 2.5 years

ID	Title	Description
OG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Secondary

Median Event-free Survival (EFS) in Months

Median and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for EFS. EFS will be estimated using the product limit method of Kaplan and Meier.

EFS is defined by time to disease recurrence, disease progression or death to due to any cause

Posted

Median

95% Confidence Interval

months

From the date treatment begins until the first date on which recurrence, progression or death due to any cause, assessed up to 3.5 years

ID	Title	Description
OG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Units	Counts
Participants

Secondary

Number of Participants Requiring Dose Reductions

Number of participants requiring a dose reduction is reported and analysis was performed using a student's 2 sample t test to determine the need of dose reductions based on age, AUC, and CL.

Posted

Count of Participants

Participants

At the completion of treatment, up to 2.5 years

ID	Title	Description
OG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Dose Omission

Number of participants with a dose omission is reported and analysis was performed using a student's 2 sample t test to determine the need of dose omission based on age, AUC, and CL.

Posted

Count of Participants

Participants

At the completion of treatment, up to 2.5 years

ID	Title	Description
OG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Units	Counts
Participants	OG000

Secondary

Percent of Participants With a Grade 3 Toxicity

Percent of participants experiencing a grade 3 toxicity is reported and analysis was performed using a student's 2 sample t test to determine the presence of grade 3 toxicity based on age, AUC, and CL.

Posted

Number

95% Confidence Interval

percentage of participants

At the completion of treatment, up to 2.5 years

ID	Title	Description
OG000	Nab-paclitaxel	paclitaxel albumin-stabilized nanoparticle formulation: 100 mg/m2 3 weeks on 1 week off pharmacological study: Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours physiologic testing: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy questionnaire administration: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy study of socioeconomic and demographic variables: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy cognitive assessment: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy psychosocial assessment and care: Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Allergic rhinitis	Immune system disorders	Systematic Assessment	EG0004 affected39 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 affected39 at risk
Immune system disorder	Immune system disorders	Systematic Assessment	EG0001 affected39 at risk
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected39 at risk
Hemoglobin decreased	Investigations	Systematic Assessment	EG00036 affected39 at risk
Leukocyte count decreased	Investigations	Systematic Assessment	EG00027 affected39 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG00015 affected39 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG00019 affected39 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0007 affected39 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0001 affected39 at risk
Hypertension	Cardiac disorders	Systematic Assessment	EG0008 affected39 at risk
Edema	General disorders	Systematic Assessment	EG0001 affected39 at risk
Activated partial thromboplastin time prolonged	Investigations	Systematic Assessment	EG0001 affected39 at risk
Chills	General disorders	Systematic Assessment	EG0001 affected39 at risk
Fatigue	General disorders	Systematic Assessment	EG00027 affected39 at risk
Fever	General disorders	Systematic Assessment	EG0003 affected39 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0002 affected39 at risk
Obesity	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected39 at risk
Sweating	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected39 at risk
Weight gain	Investigations	Systematic Assessment	EG0001 affected39 at risk
Weight loss	Investigations	Systematic Assessment	EG0003 affected39 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected39 at risk
Hand-and-foot syndrome	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected39 at risk
Injection site reaction	General disorders	Systematic Assessment	EG0001 affected39 at risk
Nail disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected39 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0003 affected39 at risk
Rash desquamating	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0009 affected39 at risk
Skin disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0005 affected39 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected39 at risk
Glucose intolerance	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected39 at risk
Hot flashes	Vascular disorders	Systematic Assessment	EG0008 affected39 at risk
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0001 affected39 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected39 at risk
Ascites	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0008 affected39 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected39 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00011 affected39 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0003 affected39 at risk
Enteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Gastric ulcer	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Hemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00015 affected39 at risk
Mucositis	Gastrointestinal disorders	Systematic Assessment	EG0002 affected39 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0002 affected39 at risk
Typhlitis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0007 affected39 at risk
Hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0003 affected39 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Ureteric hemorrhage	Renal and urinary disorders	Systematic Assessment	EG0001 affected39 at risk
Hepatobiliary disease	Hepatobiliary disorders	Systematic Assessment	EG0001 affected39 at risk
Bladder infection	Infections and infestations	Systematic Assessment	EG0002 affected39 at risk
Catheter related infection	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Gingival infection	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Infection	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Infectious colitis	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Pharyngitis	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Scrotal infection	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0004 affected39 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Small intestine infection	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Upper aerodigestive tract infection	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0008 affected39 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0004 affected39 at risk
Infection without neutropenia	Infections and infestations	Systematic Assessment	EG0001 affected39 at risk
Edema limbs	General disorders	Systematic Assessment	EG00011 affected39 at risk
Fibrosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected39 at risk
Localized edema	General disorders	Systematic Assessment	EG0003 affected39 at risk
Lymphedema	Vascular disorders	Systematic Assessment	EG0001 affected39 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0008 affected39 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG00022 affected39 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG00025 affected39 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG00023 affected39 at risk
Creatine phosphokinase increased	Investigations	Systematic Assessment	EG0001 affected39 at risk
Creatinine increased	Investigations	Systematic Assessment	EG0005 affected39 at risk
Protein urine positive	Investigations	Systematic Assessment	EG0001 affected39 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG00013 affected39 at risk
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0006 affected39 at risk
Hypercalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected39 at risk
Hypercholesteremia	Metabolism and nutrition disorders	Systematic Assessment	EG0006 affected39 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0005 affected39 at risk
Hypermagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected39 at risk
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected39 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG00010 affected39 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected39 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG00012 affected39 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected39 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected39 at risk
Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected39 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected39 at risk
Agitation	Psychiatric disorders	Systematic Assessment	EG0001 affected39 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG00011 affected39 at risk
Ataxia	Nervous system disorders	Systematic Assessment	EG0001 affected39 at risk
Cognitive disturbance	Nervous system disorders	Systematic Assessment	EG0001 affected39 at risk
Confusion	Psychiatric disorders	Systematic Assessment	EG0003 affected39 at risk
Depressed level of consciousness	Nervous system disorders	Systematic Assessment	EG0002 affected39 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0005 affected39 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0004 affected39 at risk
Memory impairment	Nervous system disorders	Systematic Assessment	EG0004 affected39 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG00019 affected39 at risk
Tremor	Nervous system disorders	Systematic Assessment	EG0001 affected39 at risk
Trigeminal nerve disorder	Nervous system disorders	Systematic Assessment	EG0001 affected39 at risk
Dry eye syndrome	Eye disorders	Systematic Assessment	EG0005 affected39 at risk
Eyelid function disorder	Eye disorders	Systematic Assessment	EG0001 affected39 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0001 affected39 at risk
Watering eyes	Eye disorders	Systematic Assessment	EG0003 affected39 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG00010 affected39 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00014 affected39 at risk
Bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 affected39 at risk
Breast pain	Reproductive system and breast disorders	Systematic Assessment	EG0002 affected39 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected39 at risk
Chest pain	Cardiac disorders	Systematic Assessment	EG0004 affected39 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected39 at risk
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected39 at risk
External ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected39 at risk
Facial pain	General disorders	Systematic Assessment	EG0001 affected39 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0007 affected39 at risk
Joint pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00012 affected39 at risk
Lymph node pain	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected39 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 affected39 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 affected39 at risk
Pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 affected39 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 affected39 at risk
Pelvic pain	Reproductive system and breast disorders	Systematic Assessment	EG0002 affected39 at risk
Peritoneal pain	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Stomach pain	Gastrointestinal disorders	Systematic Assessment	EG0001 affected39 at risk
Urethral pain	Renal and urinary disorders	Systematic Assessment	EG0001 affected39 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00011 affected39 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0008 affected39 at risk
Laryngeal edema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected39 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected39 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected39 at risk
Cystitis	Renal and urinary disorders	Systematic Assessment	EG0001 affected39 at risk
Ureteric obstruction	Renal and urinary disorders	Systematic Assessment	EG0002 affected39 at risk
Urinary frequency	Renal and urinary disorders	Systematic Assessment	EG0001 affected39 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0001 affected39 at risk
Urine discoloration	Renal and urinary disorders	Systematic Assessment	EG0001 affected39 at risk
Urogenital disorder	Renal and urinary disorders	Systematic Assessment	EG0001 affected39 at risk
Irregular menstruation	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected39 at risk
Vaginal dryness	Reproductive system and breast disorders	Systematic Assessment	EG0002 affected39 at risk

ID	Term
D001943	Breast Neoplasms
D018567	Breast Neoplasms, Male

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D013660	Taxes
D000073216	Mental Status and Dementia Tests
D000067250	Psychiatric Rehabilitation

ID	Term
D004467	Economics
D004472	Health Care Economics and Organizations
D009483	Neuropsychological Tests
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities
D012046	Rehabilitation
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services