Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Ly... | NCT00117598

Label	Type	Intervention Names
A	Experimental	Drug: Temsirolimus (CCI-779)
B	Experimental	Drug: Temsirolimus (CCI-779)
C	Active Comparator	Drug: Investigator's choice

Name	Type	Description	Arm Group Labels	Other Names
Temsirolimus (CCI-779)	Drug	Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week	A

Measure	Description	Time Frame
Progression-Free Survival (PFS)	The period from randomization until disease progression, death or date of last contact.	Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

Measure	Description	Time Frame
Percentage of Participants With Objective Response	Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.

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 5 years
Time to Response

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

PubMed Identifier	Type	Citation	Retractions
25938001	Derived	Hess G, Coiffier B, Crump M, Gisselbrecht C, Offner F, Romaguera J, Kang L, Moran PJ. Effect of prognostic classification on temsirolimus efficacy and safety in patients with relapsed or refractory mantle cell lymphoma: a retrospective analysis. Exp Hematol Oncol. 2015 Apr 11;4:11. doi: 10.1186/s40164-015-0006-1. eCollection 2015.

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

ID	Title	Description
FG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
FG001	Temsirolimus 175/25 mg

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

Progression-Free Survival (PFS)

The period from randomization until disease progression, death or date of last contact.

Intent-to-Treat (ITT) Population: All randomized participants at time of primary analysis

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

ID	Title	Description
OG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG002	Investigator's Choice	Participants received 1 single-agent treatment, chosen by investigator: Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed; Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days; Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days; Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days; Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles; Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days; Prednisone 40 (20-60) mg/m^2 PO daily or every other day; Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days.

Units	Counts
Participants	OG00054 OG00154 OG00254

Title

Denominators

Categories

Title	Measurements
	OG0004.8(2.9 to 7.0) OG0013.7(3.4 to 6.2) OG0021.8(1.6 to 2.0)

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 OG002	Two null hypotheses (Ho) tested: 1. PFS distributions for temsirolimus 175/75 mg and investigator's choice treatment groups are identical. 2. PFS distributions for temsirolimus 175/25 mg and investigator's choice treatment groups are identical. Alternative hypothesis (Ha) for each test was that PFS distributions differed.	Log Rank		<0.0001		Hazard Ratio (HR)	0.39			2-Sided	95	0.25	0.63			HR from a cox model adjusted for baseline stratification factors	No	Superiority or Other

Secondary

Percentage of Participants With Objective Response

Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.

ITT

Posted

Number

95% Confidence Interval

percentage of participants

Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

ID	Title	Description
OG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG002	Investigator's Choice

Other Pre-specified

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.

ITT

Posted

Median

95% Confidence Interval

months

Baseline up to 5 years

ID	Title	Description
OG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG002	Investigator's Choice	Participants received 1 single-agent treatment, chosen by investigator: Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed; Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days; Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days; Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days; Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles; Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days; Prednisone 40 (20-60) mg/m^2 PO daily or every other day; Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days.

Other Pre-specified

Time to Response

Time between the date of randomization and the first date of objective response for participants with a confirmed objective response.

ITT subset of participants with a confirmed objective response

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

ID	Title	Description
OG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG002	Investigator's Choice	Participants received 1 single-agent treatment, chosen by investigator: Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed; Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days; Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days; Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days; Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles; Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days; Prednisone 40 (20-60) mg/m^2 PO daily or every other day; Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days.

Other Pre-specified

Duration of Response

Time from the first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented; censored at last valid tumor assessment.

ITT subset of participants who had a response

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

ID	Title	Description
OG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG002	Investigator's Choice	Participants received 1 single-agent treatment, chosen by investigator: Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed; Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days; Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days; Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days; Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles; Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days; Prednisone 40 (20-60) mg/m^2 PO daily or every other day; Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days.

Other Pre-specified

Time to Failure (TTF)

TTF is defined as the time from randomization to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death (any cause).

ITT

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

ID	Title	Description
OG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG002	Investigator's Choice	Participants received 1 single-agent treatment, chosen by investigator: Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed; Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days; Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days; Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days; Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles; Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days; Prednisone 40 (20-60) mg/m^2 PO daily or every other day; Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days.

Other Pre-specified

Time to Tumor Progression (TTP)

TTP: time from randomization to first documentation of objective tumor progression (including recurrence); censored at last valid tumor assessment.

ITT

Posted

Median

95% Confidence Interval

months

Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

ID	Title	Description
OG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
OG002	Investigator's Choice	Participants received 1 single-agent treatment, chosen by investigator: Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed; Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days; Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days; Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days; Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles; Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days; Prednisone 40 (20-60) mg/m^2 PO daily or every other day; Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal Pain	General disorders	COSTART, 5th edition	Non-systematic Assessment	Body as a whole	EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG0030 affected3 at risk EG004
Accidental Injury	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Asthenia	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0013 affected56 at risk EG0022 affected54 at risk EG003
Back Pain	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Cellulitis	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Chills	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Fever	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0008 affected57 at risk EG0017 affected56 at risk EG0021 affected54 at risk EG003
General Physical Health Deterioration	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0013 affected56 at risk EG0021 affected54 at risk EG003
Headache	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Infection	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0012 affected56 at risk EG0022 affected54 at risk EG003
Neutropenic Fever	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0011 affected56 at risk EG0021 affected54 at risk EG003
Sepsis	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0011 affected56 at risk EG0021 affected54 at risk EG003
Septic Shock	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Angina Pectoris	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment	Cardiovascular System	EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Atrial Flutter	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Cerebrovascular Accident	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Endocarditis	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Heart Failure	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Hypervolemia	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Pulmonary Embolus	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Syncope	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Tachycardia	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Ventricular Tachycardia	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Anorexia	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment	Digestive System	EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Diarrhea	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0014 affected56 at risk EG0020 affected54 at risk EG003
Duodenal Ulcer Perforation	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Enteritis	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Gastritis	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Gastroenteritis	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Gastrointestinal Hemorrhage	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Liver Function Tests Abnormal	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Melena	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Mouth Ulceration	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Rectal Disorder	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Rectal Hemorrhage	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Stomatitis	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Ulcerative Colitis	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Acute Lymphoblastic Leukemia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment	Hemic And Lymphatic System	EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Leukopenia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Lymphoma	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0012 affected56 at risk EG0021 affected54 at risk EG003
Neutropenia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0022 affected54 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0014 affected56 at risk EG0020 affected54 at risk EG003
Creatinine Increased	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment	Metabolic And Nutritional	EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Dehydration	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Edema	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Peripheral Edema	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Facial Paralysis	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment	Nervous System	EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Neuralgia	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Somnolence	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Bronchitis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment	Respiratory System	EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Carcinoma Of Lung	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Cough Increased	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0012 affected56 at risk EG0021 affected54 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Eosinophilic Pneumonia	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Hyperventilation	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Interstitial Pneumonia	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Lung Disorder	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Lung Edema	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Lung Fibrosis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Lung Infiltration Nos	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0021 affected54 at risk EG003
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0014 affected56 at risk EG0022 affected54 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Rhinitis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Acne	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment	Skin And Appendages	EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Fungal Dermatitis	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Herpes Zoster	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Rash	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Skin Carcinoma	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Conjunctivitis	Eye disorders	COSTART, 5th edition	Non-systematic Assessment	Special Senses	EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Acute Kidney Failure	Renal and urinary disorders	COSTART, 5th edition	Non-systematic Assessment	Urogenital System	EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Genital Edema	Renal and urinary disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Kidney Function Abnormal	Renal and urinary disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Urinary Retention	Renal and urinary disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal Pain	General disorders	COSTART, 5th edition	Non-systematic Assessment	Body As A Whole	EG00014 affected57 at risk EG00116 affected56 at risk EG0029 affected54 at risk EG0030 affected3 at risk EG004
Accidental Injury	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0016 affected56 at risk EG0021 affected54 at risk EG003
Asthenia	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG00038 affected57 at risk EG00134 affected56 at risk EG00213 affected54 at risk EG003
Back Pain	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0008 affected57 at risk EG0018 affected56 at risk EG0022 affected54 at risk EG003
Cellulitis	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0012 affected56 at risk EG0022 affected54 at risk EG003
Chest Pain	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0014 affected56 at risk EG0022 affected54 at risk EG003
Chills	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG00014 affected57 at risk EG0015 affected56 at risk EG0026 affected54 at risk EG003
Face Edema	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Fever	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG00021 affected57 at risk EG00116 affected56 at risk EG00217 affected54 at risk EG003
Flu Syndrome	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0015 affected56 at risk EG0021 affected54 at risk EG003
Headache	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0009 affected57 at risk EG00113 affected56 at risk EG0025 affected54 at risk EG003
Hernia	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Infection	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG00017 affected57 at risk EG00115 affected56 at risk EG0023 affected54 at risk EG003
Neoplasm	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Non-Specified Drug Reaction	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Pain	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG00019 affected57 at risk EG00113 affected56 at risk EG0022 affected54 at risk EG003
Pelvic Pain	General disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0013 affected56 at risk EG0021 affected54 at risk EG003
Hemorrhage	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment	Cardiovascular System	EG0003 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Hypertension	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0015 affected56 at risk EG0020 affected54 at risk EG003
Hypotension	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0014 affected56 at risk EG0022 affected54 at risk EG003
Tachycardia	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0005 affected57 at risk EG0014 affected56 at risk EG0022 affected54 at risk EG003
Tachycardia Sinus	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Thrombophlebitis	Cardiac disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Abdominal Distension	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment	Digestive System	EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Anorexia	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG00023 affected57 at risk EG00117 affected56 at risk EG0028 affected54 at risk EG003
Aphthous Stomatitis	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0014 affected56 at risk EG0020 affected54 at risk EG003
Blood In Stool	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Constipation	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0009 affected57 at risk EG0014 affected56 at risk EG00210 affected54 at risk EG003
Diarrhea	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG00026 affected57 at risk EG00119 affected56 at risk EG0026 affected54 at risk EG003
Dry Mouth	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0012 affected56 at risk EG0021 affected54 at risk EG003
Dyspspsia	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0012 affected56 at risk EG0023 affected54 at risk EG003
Dysphagia	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Melena	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Mouth Pain	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Mouth Ulceration	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0015 affected56 at risk EG0020 affected54 at risk EG003
Mucositis	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG00021 affected57 at risk EG0019 affected56 at risk EG0020 affected54 at risk EG003
Nausea	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG00014 affected57 at risk EG00117 affected56 at risk EG00211 affected54 at risk EG003
Rectal Hemorrhage	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0005 affected57 at risk EG0011 affected56 at risk EG0021 affected54 at risk EG003
Stomatitis	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG00012 affected57 at risk EG0016 affected56 at risk EG0023 affected54 at risk EG003
Vomiting	Gastrointestinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0008 affected57 at risk EG0017 affected56 at risk EG0023 affected54 at risk EG003
Anemia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment	Hemic And Lymphatic System	EG00031 affected57 at risk EG00130 affected56 at risk EG00224 affected54 at risk EG003
Ecchymosis	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0014 affected56 at risk EG0022 affected54 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0013 affected56 at risk EG0021 affected54 at risk EG003
Leukopenia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG00010 affected57 at risk EG00112 affected56 at risk EG00222 affected54 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0012 affected56 at risk EG0022 affected54 at risk EG003
Lymphedema	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Lymphocytosis	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0007 affected57 at risk EG0017 affected56 at risk EG00210 affected54 at risk EG003
Neutropenia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG00015 affected57 at risk EG00119 affected56 at risk EG00222 affected54 at risk EG003
Prothrombin Time Prolonged	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	COSTART, 5th edition	Non-systematic Assessment		EG00045 affected57 at risk EG00147 affected56 at risk EG00229 affected54 at risk EG003
Creatinine Increased	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment	Metabolic And Nutritional	EG0005 affected57 at risk EG0017 affected56 at risk EG0020 affected54 at risk EG003
Dehydration	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0014 affected56 at risk EG0020 affected54 at risk EG003
Edema	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0016 affected56 at risk EG0026 affected54 at risk EG003
Gamma Globulin Decreased	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Hypercholesteremia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG00011 affected57 at risk EG00110 affected56 at risk EG0020 affected54 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0009 affected57 at risk EG0016 affected56 at risk EG0026 affected54 at risk EG003
Hyperlipemia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0007 affected57 at risk EG00111 affected56 at risk EG0020 affected54 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0015 affected56 at risk EG0020 affected54 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG00014 affected57 at risk EG00110 affected56 at risk EG0021 affected54 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Hypophosphatemia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0007 affected57 at risk EG0016 affected56 at risk EG0020 affected54 at risk EG003
Hypoproteinemia	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Lactic Dehydrogenase Increased	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0015 affected56 at risk EG0021 affected54 at risk EG003
Peripheral Edema	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG00014 affected57 at risk EG00113 affected56 at risk EG0029 affected54 at risk EG003
SGOT Increased	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0016 affected56 at risk EG0021 affected54 at risk EG003
SGPT Increased	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0013 affected56 at risk EG0021 affected54 at risk EG003
Weight Gain	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Weight Loss	Metabolism and nutrition disorders	COSTART, 5th edition	Non-systematic Assessment		EG00010 affected57 at risk EG00112 affected56 at risk EG0025 affected54 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	COSTART, 5th edition	Non-systematic Assessment	Musculoskeletal System	EG00012 affected57 at risk EG0015 affected56 at risk EG0021 affected54 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Joint Disorder	Musculoskeletal and connective tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Leg Cramps	Musculoskeletal and connective tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0013 affected56 at risk EG0021 affected54 at risk EG003
Muscle Cramp	Musculoskeletal and connective tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0007 affected57 at risk EG0012 affected56 at risk EG0021 affected54 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0005 affected57 at risk EG0013 affected56 at risk EG0021 affected54 at risk EG003
Anxiety	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment	Nervous System	EG0009 affected57 at risk EG0014 affected56 at risk EG0023 affected54 at risk EG003
Depression	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0005 affected57 at risk EG0015 affected56 at risk EG0020 affected54 at risk EG003
Dizziness	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0016 affected56 at risk EG0021 affected54 at risk EG003
Insomnia	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment		EG00012 affected57 at risk EG0016 affected56 at risk EG0024 affected54 at risk EG003
Neuropathy	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0002 affected57 at risk EG0014 affected56 at risk EG0021 affected54 at risk EG003
Paresthesia	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0016 affected56 at risk EG0023 affected54 at risk EG003
Sleep Disorder	Nervous system disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Bronchitis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment	Respiratory System	EG0004 affected57 at risk EG0013 affected56 at risk EG0023 affected54 at risk EG003
Cough Increased	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG00019 affected57 at risk EG00118 affected56 at risk EG0025 affected54 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG00013 affected57 at risk EG00112 affected56 at risk EG00216 affected54 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG00026 affected57 at risk EG00116 affected56 at risk EG0023 affected54 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Pharyngitis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0007 affected57 at risk EG0019 affected56 at risk EG0024 affected54 at risk EG003
Pleural Disorder	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0013 affected56 at risk EG0024 affected54 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0018 affected56 at risk EG0025 affected54 at risk EG003
Pulmonary Physical Finding	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0015 affected56 at risk EG0022 affected54 at risk EG003
Rhinitis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0015 affected56 at risk EG0023 affected54 at risk EG003
Sinusitis	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Upper Respiratory Infection	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0009 affected57 at risk EG0014 affected56 at risk EG0022 affected54 at risk EG003
Voice Alteration	Respiratory, thoracic and mediastinal disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Acne	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment	Skin And Appendages	EG0005 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0007 affected57 at risk EG0015 affected56 at risk EG0021 affected54 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG0011 affected56 at risk EG0022 affected54 at risk EG003
Fungal Dermatitis	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Herpes Simplex	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0006 affected57 at risk EG00110 affected56 at risk EG0024 affected54 at risk EG003
Maculopapular Rash	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0013 affected56 at risk EG0021 affected54 at risk EG003
Nail Disorder	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG00011 affected57 at risk EG00110 affected56 at risk EG0021 affected54 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0005 affected57 at risk EG0013 affected56 at risk EG0024 affected54 at risk EG003
Pruritic Rash	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0005 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG00016 affected57 at risk EG00112 affected56 at risk EG0023 affected54 at risk EG003
Rash	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG00021 affected57 at risk EG00119 affected56 at risk EG0026 affected54 at risk EG003
Skin Carcinoma	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Skin Disorder	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Sweating	Skin and subcutaneous tissue disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0013 affected56 at risk EG0027 affected54 at risk EG003
Abnormal Vision	Eye disorders	COSTART, 5th edition	Non-systematic Assessment	Special Senses	EG0003 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Conjunctivitis	Eye disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0012 affected56 at risk EG0020 affected54 at risk EG003
Diplopia	Eye disorders	COSTART, 5th edition	Non-systematic Assessment		EG0000 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Eye Disorder	Eye disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0010 affected56 at risk EG0020 affected54 at risk EG003
Eye Hemorrhage	Eye disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Parosmia	Eye disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0010 affected56 at risk EG0021 affected54 at risk EG003
Taste Loss	Eye disorders	COSTART, 5th edition	Non-systematic Assessment		EG0005 affected57 at risk EG0013 affected56 at risk EG0020 affected54 at risk EG003
Taste Perversion	Eye disorders	COSTART, 5th edition	Non-systematic Assessment		EG0009 affected57 at risk EG0012 affected56 at risk EG0021 affected54 at risk EG003
Dysuria	Renal and urinary disorders	COSTART, 5th edition	Non-systematic Assessment	Urogenital System	EG0004 affected57 at risk EG0015 affected56 at risk EG0021 affected54 at risk EG003
Hematuria	Renal and urinary disorders	COSTART, 5th edition	Non-systematic Assessment		EG0001 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Urinary Frequency	Renal and urinary disorders	COSTART, 5th edition	Non-systematic Assessment		EG0004 affected57 at risk EG0011 affected56 at risk EG0020 affected54 at risk EG003
Urinary Tract Infection	Renal and urinary disorders	COSTART, 5th edition	Non-systematic Assessment		EG0003 affected57 at risk EG0015 affected56 at risk EG0020 affected54 at risk EG003
Local Reaction To Procedure	Investigations	COSTART, 5th edition	Non-systematic Assessment	Adverse Event Associated with Miscellaneous factors	EG0003 affected57 at risk EG0013 affected56 at risk EG0021 affected54 at risk EG003

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Title	Description
BG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
BG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
BG002	Investigator's Choice	Participants received 1 single-agent treatment, chosen by investigator: Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed; Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days; Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days; Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days; Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles; Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days; Prednisone 40 (20-60) mg/m^2 PO daily or every other day; Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Temsirolimus 175/75 mg	Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Includes participants who received Temsirolimus 175/75 mg prior to crossover (Protocol Amendment 5).	34	57	57	57
EG001	Temsirolimus 175/25 mg	Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.	34	56	56	56
EG002	Investigator's Choice	Participants received 1 single-agent treatment, chosen by investigator: Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed; Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days; Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days; Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days; Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles; Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days; Prednisone 40 (20-60) mg/m^2 PO daily or every other day; Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days.	14	54	52	54
EG003	Temsirolimus 175/25 mg Then 75 mg	Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Adverse events (AEs) presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.	1	3	3	3
EG004	Investigator's Choice Then Temsirolimus 175/75 mg	Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. AEs presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.	1	4	4	4