Randomized Trial of Lenalidomide, Bortezomib, Dexamethaso... | NCT01208662

Status Module

Name	Class
Celgene Corporation	INDUSTRY
Millennium Pharmaceuticals, Inc.	INDUSTRY
Massachusetts General Hospital	OTHER
Cape Cod Hospital

Oversight Module

Description Module

Detailed Description

The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have not been approved in the combination for multiple myeloma or any other type of cancer. Bortezomib is currently approved by the FDA for the treatment of multiple myeloma. Lenalidomide is approved for use with dexamethasone for patients with multiple myeloma who have received at least one prior therapy and for the treatment of certain types of myelodysplastic syndrome (another type of cancer affecting the blood). Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Please note that Bortezomib and Lenalidomide are provided to patients participating in this trial at no charge. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as a high-dose conditioning treatment prior to stem cell transplantation. Cyclophosphamide is used, either alone, or in combination with other drugs, to treat multiple myeloma. These drugs have been used in other multiple myeloma studies and information from those studies suggests that this combination of therapy may help to treat newly diagnosed multiple myeloma.

After screening procedures determine if a patient is eligible for this research study, the patient will be randomized into one of the study groups: lenalidomide, bortezomib and dexamethasone without autologous stem cell transplantation, followed by lenalidomide maintenance (Arm A) or lenalidomide, bortezomib and dexamethasone with autologous stem cell transplantation, followed by lenalidomide maintenance (Arm B). There is an equal chance of being placed in either group. Randomization was stratified by International Staging System (ISS) disease stage (I, II, or III) and cytogenetics (high-risk [presence of 17p deletion, t(4;14), or t(14;16) on fluorescence in-situ hybridization], standard-risk [absence of high-risk abnormalities], or undetermined [test failure]) assessed locally in a screening bone marrow sample, with positivity cut-offs per institutional standards.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RVD Alone	Experimental	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12	Drug: Lenalidomide Drug: Bortezomib Drug: Dexamethasone
RVD plus ASCT	Active Comparator	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12	Drug: Lenalidomide Drug: Bortezomib Drug: Dexamethasone Procedure: Autologous Stem Cell Transplant

Name	Type	Description	Arm Group Labels	Other Names
Lenalidomide	Drug	oral administration	RVD Alone RVD plus ASCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Median Progression-Free Survival (PFS)	PFS was estimated using the Kaplan-Meier (KM) method and defined as time from randomization to the earlier of disease progression (PD) as determined by central review or death from any cause (events). Patients who started non-protocol therapy (NPT) were censored at the date of NPT initiation if available or date treatment ended if date of NPT was missing. Deaths occurring beyond 1 year from the date last known progression-free are not counted as events and censored at date of last disease evaluation. Patients who had not started NPT, progressed, or died were censored at the date of last disease evaluation. PD was based upon the International Myeloma Working Group (IMWG) uniform response criteria. [Kumar S, et al Lancet Oncol 2016;17(8):e328-e346].	On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) PFS follow-up was 70 and 129 months.

Secondary Outcomes

Measure	Description	Time Frame
Partial Response (PR) Rate	The PR rate is the percentage of participants achieving PR or better on treatment and was evaluated based on the IMWG criteria. PR was defined as > 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by > 90% or to < 200mg per 24 hours. If the serum and urine M-protein are unmeasurable, a > 50% decrease in the difference between involved and uninvolved free light chain levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, >50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was > 30%. In addition to the above listed criteria, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas was also required. Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic Criteria
Documented symptomatic myeloma, with organ damage related to myeloma with laboratory assessments performed within 21 days of registration
Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains.
ECOG performance status </= 2
Negative HIV blood test
Voluntary written informed consent

Exclusion Criteria:

Pregnant or lactating female
Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days before study entry, corticosteroids allowed if dose </= equivalent of 160 mg dexamethasone over 2 weeks)
Primary amyloidosis (AL) or myeloma complicated by amylosis
Receiving any other investigational agents
Known brain metastases
Poor tolerability or allergy to any of the study drugs or compounds of similar composition
Platelet count <50,000/mm3, within 21 days of registration
ANC <1,000 cells/mm3, within 21 days of registration
Hemoglobin <8 g/dL, within 21 days of registration
Hepatic impairment (>/= 1.5 x institutional ULN or AST (SGOT), ALT (SGPT), or alkaline phosphatase >2 x ULN). Patients with benign hyperbilirubinemia are eligible.
Renal insufficiency (serum creatinine >2.0 mg/dl or creatinine clearance <50 ml/min, within 21 days of registration)
Respiratory compromise (DLCO < 50%)
Clinical signs of heart or coronary failure or LVEF < 40%. Myocardial infarction within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system abnormalities
Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements
Previous history of another malignant condition except for basal cell carcinoma and stage I cervical cancer. If malignancy was experienced more than 2 years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion.
Inability to comply with an anti-thrombotic treatment regimen
Peripheral neuropathy >/= Grade 2

Name	Affiliation	Role
Paul G. Richardson, MD	Dana-Farber Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Arizona Comprehensive Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35660812	Result	Richardson PG, Jacobus SJ, Weller EA, Hassoun H, Lonial S, Raje NS, Medvedova E, McCarthy PL, Libby EN, Voorhees PM, Orlowski RZ, Anderson LD Jr, Zonder JA, Milner CP, Gasparetto C, Agha ME, Khan AM, Hurd DD, Gowin K, Kamble RT, Jagannath S, Nathwani N, Alsina M, Cornell RF, Hashmi H, Campagnaro EL, Andreescu AC, Gentile T, Liedtke M, Godby KN, Cohen AD, Openshaw TH, Pasquini MC, Giralt SA, Kaufman JL, Yee AJ, Scott E, Torka P, Foley A, Fulciniti M, Hebert K, Samur MK, Masone K, Maglio ME, Zeytoonjian AA, Nadeem O, Schlossman RL, Laubach JP, Paba-Prada C, Ghobrial IM, Perrot A, Moreau P, Avet-Loiseau H, Attal M, Anderson KC, Munshi NC; DETERMINATION Investigators. Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma. N Engl J Med. 2022 Jul 14;387(2):132-147. doi: 10.1056/NEJMoa2204925. Epub 2022 Jun 5.
34549906

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RVD Alone	All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 12, 2023	Sep 29, 2023

Arm/Group Information

ID	Title	Description
BG000	RVD Alone	All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
BG001	RVD Plus ASCT	All participants received one cycle of lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
BG002	RVD Cycle 1 Only	Some participants started cycle 1 lenalidomide (R), bortezomib (V) and dexamethasone (D) therapy but were not randomized. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
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

Median

Inter-Quartile Range

years

Title	Denominators	Categories
	ParticipantsBG000357 ParticipantsBG001365 ParticipantsBG0027 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000357 ParticipantsBG001365 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000357 ParticipantsBG001365 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
White	ParticipantsBG000357 ParticipantsBG001365 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
United States	ParticipantsBG000357 ParticipantsBG001365 ParticipantsBG002

ISS Multiple Myeloma Stage

The International Staging System (ISS) consists of three stages: stage I, serum beta 2-microglobulin level lower than 3.5 mg per liter and serum albumin level 3.5 g per deciliter or higher; stage II, neither stage I nor III; and stage III, serum beta 2-microglobulin level 5.5 mg per liter or higher. Higher stages indicate more severe disease.

ISS Multiple Myeloma staging data collected at randomization and therefore data was not collected for the seven participants who were not randomized.

Count of Participants

Participants

Title	Denominators	Categories
I	ParticipantsBG000357 ParticipantsBG001

Cytogenetic Risk Category

Cytogenetic risk was based on FISH or karyotype analysis; patients who had a high-risk cytogenetic profile had at least one high-risk abnormality (t[4;14], t[14;16], or del17p). Patients with standard risk had no high-risk cytogenetic abnormalities.

Cytogenetic risk category data collected at randomization and therefore data was not collected for the seven participants who were not randomized.

Count of Participants

Participants

Title	Denominators	Categories
High risk	ParticipantsBG000357 ParticipantsBG001365

BMI

The body-mass index (BMI) is the weight in kilograms divided by the square of the height in meters.

Count of Participants

Participants

Title	Denominators	Categories
<25	ParticipantsBG000357 ParticipantsBG001365 ParticipantsBG002

ECOG Performance Status

Eastern Cooperative Oncology Group (ECOG) Performance Status: (PS0) Fully active, able to carry on all pre-disease performance without restriction (PS1) Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (PS2) Ambulatory and capable of all self-care but unable to carry out any work activities; Up and about >50% of waking hours.

Count of Participants

Participants

Title	Denominators	Categories
0	ParticipantsBG000357 ParticipantsBG001365 Participants

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

Median Progression-Free Survival (PFS)

PFS was estimated using the Kaplan-Meier (KM) method and defined as time from randomization to the earlier of disease progression (PD) as determined by central review or death from any cause (events). Patients who started non-protocol therapy (NPT) were censored at the date of NPT initiation if available or date treatment ended if date of NPT was missing. Deaths occurring beyond 1 year from the date last known progression-free are not counted as events and censored at date of last disease evaluation. Patients who had not started NPT, progressed, or died were censored at the date of last disease evaluation. PD was based upon the International Myeloma Working Group (IMWG) uniform response criteria. [Kumar S, et al Lancet Oncol 2016;17(8):e328-e346].

The analysis population is comprised of all randomized participants.

Posted

Median

95% Confidence Interval

months

On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) PFS follow-up was 70 and 129 months.

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001	RVD Plus ASCT	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Units	Counts
Participants	OG000357 OG001365

Title

Denominators

Categories

Title	Measurements
	OG00046.2(38.1 to 53.7) OG00167.5(58.6 to NA)95% CI upper bound not estimable because data not mature enough. Specifically, with the follow-up observed as of data extraction, there were not enough events.

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	Observed Stratified Log Rank Test (1-sided p-value)	<0.001		Hazard Ratio (HR)	1.53			2-Sided	95	1.23	1.91					Superiority

Secondary

Partial Response (PR) Rate

The PR rate is the percentage of participants achieving PR or better on treatment and was evaluated based on the IMWG criteria. PR was defined as > 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by > 90% or to < 200mg per 24 hours. If the serum and urine M-protein are unmeasurable, a > 50% decrease in the difference between involved and uninvolved free light chain levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, >50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was > 30%. In addition to the above listed criteria, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas was also required. Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.

The analysis population is comprised of all randomized participants.

Posted

Number

99.29% Confidence Interval

percentage of participants

Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort.

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Very Good Partial Response (VGPR) Rate

The VGPR rate is the percentage of participants achieving VGPR or better on treatment and was evaluated based on IMWG criteria. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hours.

The analysis population is comprised of all randomized participants.

Posted

Number

95% Confidence Interval

percentage of patients

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Complete Response (CR) Rate

The CR rate is the percentage of participants achieving CR or better on treatment and was evaluated based on IMWG criteria. CR was defined as the negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Confirmation with repeat bone marrow biopsy was not needed.

The analysis population is comprised of all randomized patients.

Posted

Number

95% Confidence Interval

percentage of patients

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Median Duration of Response: Partial Response (DOR PR)

DOR PR was estimated using the KM method and defined as the time from documented best response as CR to documented disease progression per IMWG criteria. Patients who have not progressed or died were censored at the date last known progression-free.

The analysis population is comprised of all randomized participants who achieved PR.

Posted

Median

95% Confidence Interval

months

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001	RVD Plus ASCT

Secondary

5-Year Time to Progression (TTP)

TTP was estimated using the KM method and defined as time from randomization to time of documented IMWG disease progression or censoring time (time of last disease evaluation for those alive, time to death among those who died). Patients initiating non-protocol therapy prior to progression or death were censored at the date of non-protocol therapy in the TTP analysis. The 5-year TTP endpoint is a probability.

The analysis population is comprised of all randomized participants.

Posted

Number

95% Confidence Interval

percent probability

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

5-Year Overall Survival (OS)

OS was estimated using the KM method and defined as time from randomization to death due to any cause. Patients alive were censored at date last known alive. The 5-year OS endpoint is a probability.

The analysis population is comprised of all randomized participants.

Posted

Number

95% Confidence Interval

percent probability

In long-term follow-up, survival follow-up every 2 months until death. Median (maximum) OS follow-up was 76 and 129 months.The probability estimate is at 5 years.

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001	RVD Plus ASCT	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Grade 3 or Higher Treatment-Related Non-Hematologic Adverse Event (AE) Rate

Safety was evaluated throughout trial treatment, including ASCT, and through 30 days after receipt of the last dose of a trial drug. Treatment attribution and grade were based on the NCI CTCAE v4. The Grade 3 or Higher Treatment-Related Non-Hematologic AE Rate is percentage of participants who experienced any grade 3-5 treatment-related (possible, probable or definite attribution) non-hematologic adverse event based on CTCAEv4 as reported on case report forms. The difference in the rate of all grade 3 or higher toxicities was compared between the two groups using Fisher's exact test.

The analysis population comprised of all randomized participants.

Posted

Number

95% Confidence Interval

percentage of participants

AEs was assessed every cycle on treatment. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort.

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

5-year Cumulative Incidence of Second Primary Malignancy (SPM)

Second primary malignancy (SPM) is defined as the development of another new, unrelated cancer, regardless of treatment for previous malignancy attribution. The cumulative incidence of SPMs was estimated with death as a competing risk. SPMs were collected using an SAE form or MEDWATCH 3500A form, with intensity determined by using the NCI CTCAE version 4 as a guideline.

The analysis population is comprised of all randomized participants.

Posted

Number

percentage of patients

5 years

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001	RVD Plus ASCT

Secondary

Median Treatment Duration

Treatment duration estimated using the KM method is defined as the time from registration (C1) to the time off treatment (event) or censored at date of last treatment.

The analysis population is comprised of all randomized participants.

Posted

Median

95% Confidence Interval

months

Up to 134 months

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001	RVD Plus ASCT	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Median Maintenance Treatment Duration

Maintenance treatment duration estimated using the KM method is defined as the time from start of maintenance to the time off maintenance (event) or censored at date of last maintenance treatment.

The analysis population is comprised of all patients that started maintenance treatment.

Posted

Median

95% Confidence Interval

months

Up to 128 months

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001	RVD Plus ASCT	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Subsequent Therapy Rate

Subsequent therapy rate was the percentage of participants who discontinued treatment and initiated subsequent non-protocol therapy.

All participants off treatment per protocol.

Posted

Count of Participants

Participants

Up to 129 months

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001	RVD Plus ASCT	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Change From Baseline on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX)

The FACT/GOG-NTX assessment consists of 11 questions that are all used to construct 1 subscale to summarize symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. (https://www.facit.org/measures/FACT-GOG-NTX) Each question has 4 possible responses from 0 (Not at all) to 4 (Very Much) which are reverse-scored and summed. This sum is then scaled by the number of questions answered by multiplying by 11 and then dividing by the number of questions that are non-blank, in order to keep all final scores proportional to one another even if some questions are left blank. The aggregate score ranges from 0 to 44, with higher scores indicating less neurotoxicity and lower scores indicating more neurotoxicity. Change from baseline is the difference

The analysis population is comprised of all randomized participants who completed the assessment both at baseline and at the respective timepoint on treatment.

Posted

Mean

Standard Deviation

units on a scale

Cycle 1 (Baseline), Cycle 2, Pre-Mobilization, Cycle 5 Arm A / Post Auto-HSCT Arm B, Cycle 8 Arm A /Cycle 5 Arm B, Maintenance Day 1, 2 years from baseline, 3 years from baseline

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Change From Baseline on the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30): Global Health Status/Quality of Life (QoL) Sub-scale

The EORTC QLQ-C30 assessment consists of 30 questions that are used to construct 15 distinct sub-scales (five function scales, nine symptom scales, and a global health status/QoL scale). The global health status/QoL scale is comprised of two questions each with a range of 6 (1=Very Poor to 7=Excellent). Scores on all sub-scales range from 0 to 100 after linear transformation of the raw scores, with higher scores representing better global health status and quality of life.

The analysis population is comprised of all randomized participants who completed the assessment both at baseline and at the respective timepoint on treatment.

Posted

Mean

Standard Deviation

units on a scale

Cycle 1 (Baseline), Cycle 2, Pre-Mobilization, Cycle 5 Arm A / Post Auto-HSCT Arm B, Cycle 8 Arm A /Cycle 5 Arm B, Maintenance Day 1, 2 years from baseline, 3 years from baseline

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Secondary

Quality-Adjusted Life Years (QALYs)

QALYs were estimated with a model beginning at initiation of first-line therapy by arm. A lifetime horizon, as well as subsequent lines of therapy, was examined using open-source Amua 0.3.0 software. Base case analysis was performed using 10,000 first-order Monte Carlo simulations. Conditional probabilities were extracted from Kaplan-Meier curves from pivotal clinical trials using WebPlotDigitizer. Costs were estimated from RED BOOK and DFCI charge reporting in US Dollars ($) after inflation adjustment to 2022 and 3% discounting, and QALYs effects were measured using EQ-5D data from Hatswell et al.

Posted

Mean

Standard Deviation

years gained

Maximum observation of survival for this study cohort was 129.4 months.

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001

Post-Hoc

Next Generation Sequencing (NGS) Minimal Residual Disease Negative (MRD-) Rate at Maintenance Start

Bone marrow aspirate samples were obtained from patients prior to the start of lenalidomide maintenance. NGS MRD- rate is the percentage of evaluable participants with MRD level of <1 x 10-5 (indicating detection of 1 malignant plasma cell in 100,000 bone marrow cells) using the validated, US Food and Drug Administration approved clonoSEQ® NGS platform (Adaptive Biotechnologies) with a minimum sensitivity of 1 x 10-5.

The analysis population is comprised of the participants with evaluable samples at baseline and start of maintenance.

Posted

Number

95% Confidence Interval

percentage of participants

Maintenance treatment occurred after induction, up to 11.5 months.

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Post-Hoc

Median Event Free Survival (EFS)

EFS was estimated using the KM method and defined as the time from randomization to the earliest of IMWG disease progression, death, or initiation of non-protocol therapy (events); patients were censored date of last disease evaluation.

The analysis population is comprised of all randomized participants.

Posted

Median

95% Confidence Interval

months

Assessed up to approximately 130 months.

ID	Title	Description
OG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
OG001	RVD Plus ASCT	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RVD Alone	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12	89	357	279	357	343	357
EG001	RVD Plus ASCT	All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12	88	365	344	365	345	365
EG002	RVD Cycle 1 Only	RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1) on days 1, 2, 4, 5, 8, 9, 11, and 12	1	7	4	7	7	7

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00065 affected357 at risk EG001108 affected365 at risk EG0021 affected7 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00015 affected357 at risk EG00133 affected365 at risk EG0020 affected7 at risk
Leukocytosis	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Leukopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00070 affected357 at risk EG001145 affected365 at risk EG0021 affected7 at risk
Lymph node pain	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lymphopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00032 affected357 at risk EG00137 affected365 at risk EG0020 affected7 at risk
Neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG000152 affected357 at risk EG001315 affected365 at risk EG0021 affected7 at risk
Pancytopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Thrombocytopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00071 affected357 at risk EG001302 affected365 at risk EG0021 affected7 at risk
Acute coronary syndrome	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0021 affected7 at risk
Acute heart failure	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acute pericarditis	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
atrial flutter	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bradycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Conduction disorder	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Congestive heart failure	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Heart block	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Heart failure	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Myocardial infarction	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Paroxysmal atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hypothyroidism	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Retinal vascular disorder	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abdominal discomfort	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Acute pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Colitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00015 affected357 at risk EG00118 affected365 at risk EG0020 affected7 at risk
Dysphasia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Esophagitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Gastric ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gastritis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gastrointestinal bleed	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lower gastrointestinal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Mucositis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00019 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG00124 affected365 at risk EG0020 affected7 at risk
Odynophagia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Oedema uvula	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rectal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Stomach pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Typhlitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Chest pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Edema NOS	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00122 affected365 at risk EG0020 affected7 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00119 affected365 at risk EG0020 affected7 at risk
Malaise	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Mucositis	General disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Pain NOS	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Physical deconditioning	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sternal pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sudden death	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Weakness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Cholecystitis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gallbladder inflammation	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hyperbilirubinemia	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Graft versus host disease	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abcess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abdominal abscess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Acute sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bacteremia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bacterial infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Breast cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Catheter infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Clostridium difficile infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Empyema	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Endocarditis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Enterocolitis infectious	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Escherichia coli infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gastroenteritis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Herpes zoster	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Infection NOS	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Influenza	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Kidney infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Leptotrichia buccalis infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lip infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lobar pneumonia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Necrotizing fasciitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nose infection NOS	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nosocomial pneumonia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Papulopustular rash	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pneumonia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00018 affected357 at risk EG00133 affected365 at risk EG0020 affected7 at risk
Respiratory syncytial virus infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sepsis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Shingles	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Soft tissue infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Stomach virus	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Streptococcal bacteremia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Streptococcal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Thrush	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Viral pneumonia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Viral syndrome	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Subdural hematoma	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Absolute lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Blood creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Creatine kinase high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Elevated liver enzymes	Investigations	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG0018 affected365 at risk EG0021 affected7 at risk
QT interval prolonged	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Weight gain	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
White blood cell count increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Decreased appetite	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG00115 affected365 at risk EG0020 affected7 at risk
Hyperuricemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00012 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected357 at risk EG00130 affected365 at risk EG0020 affected7 at risk
Metabolic acidosis	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tumor lysis syndrome	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Ache	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Muscle cramps	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Muscle spasm	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pain in elbow	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain in hand	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain in hip	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Pain in Neck	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pain joint	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rib pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acute lymphoblastic leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Acute lymphocytic leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acute myeloid leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Breast ductal cancer invasive	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Ductal carcinoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Second primary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Treatment related secondary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Brain stem stroke	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Encephalomalacia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Memory impairment	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Sensory peripheral neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00017 affected357 at risk EG00119 affected365 at risk EG0020 affected7 at risk
Somnolence	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Stroke	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Syncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Confusion	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Depression	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Mental status changes	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Incontinence	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Throat pain	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Dry skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Erythema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Facial swelling	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Photosensitivity	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00113 affected365 at risk EG0021 affected7 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Stevens Johnson syndrome	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0021 affected7 at risk
Cholecystostomy	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Deep vein thrombosis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Hypotension orthostatic	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Pulmonary embolism	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abcess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abdominal crampy pains	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Abdominal discomfort	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00120 affected365 at risk EG0020 affected7 at risk
Abdominal distension	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00026 affected357 at risk EG00124 affected365 at risk EG0020 affected7 at risk
Abdominal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abdominal wall cyst	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abnormal bowel sounds	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Abnormal sensation in ear	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abnormal sensation of limbs	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Abnormal vision	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Abrasions	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Abscess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Abscess jaw	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Abscess limb	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Abscesses of skin	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Absolute lymphocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Absolute monocyte count decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Accidental death	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Ache	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Achilles tendon pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Achilles tendonitis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Aching joints	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acid reflux	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Acne	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Activated partial thromboplastin time prolonged	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acute gastroenteritis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acute pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acute pericarditis	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Acute pharyngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Acute renal failure	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Acute renal insufficiency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Acute respiratory insufficiency	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Acute vaginitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Adenocarcinoma of prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Adrenal insufficiency	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Adverse drug reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Ageusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Aggressive reaction	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Agitation	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Alanine aminotransferase decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Albumin decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Alcohol intoxication	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Alertness decreased	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Allergic rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Allergic reaction	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00015 affected357 at risk EG00123 affected365 at risk EG0020 affected7 at risk
Allergy	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00055 affected357 at risk EG00123 affected365 at risk EG0020 affected7 at risk
Altered mood	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Amnesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Amyloid disease	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Anal bleeding	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Anal fissure	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Anal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Anal lesion	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Anal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Anaphylaxis	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Anemia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00051 affected357 at risk EG00165 affected365 at risk EG0020 affected7 at risk
Angioedema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Anisocoria	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Ankle edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00117 affected365 at risk EG0020 affected7 at risk
Ankle fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Ankle injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Anorectal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00059 affected357 at risk EG00178 affected365 at risk EG0020 affected7 at risk
Anxiety	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG00057 affected357 at risk EG00171 affected365 at risk EG0021 affected7 at risk
Anxiety depression	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Aortic aneurysm	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Appendicitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Appetite increased	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Application site bruise	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Arm discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Arm fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Arrhythmia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Arteriovenous fistula site oedema	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected357 at risk EG00155 affected365 at risk EG0020 affected7 at risk
Arthritic pains	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Articular calcification	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Articular gout	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Aspartate aminotransferase decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Asthenia	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Astigmatism	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Asystole	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Ataxia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Atherosclerosis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Athlete's foot	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Atrial flutter	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Atrophy skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Attentiveness decreased	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Atypical pneumonia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Avascular necrosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Avascular necrosis femoral head	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Axillary abscess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Axillary lump	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Back discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Back injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Back muscle spasms	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG000147 affected357 at risk EG001132 affected365 at risk EG0020 affected7 at risk
Back stiffness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Back strain	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Backache	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bacteremia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Bacterial vaginosis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Baker's cyst	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Balance disorder	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Bartholin's cyst	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Bed wetting	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Belching	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Biliary dyskinesia	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bilirubin total	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bilirubin total high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Black stools	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Bladder infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bladder prolapse	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bladder spasm	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bleeding	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Bleeding from tongue	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bleeding lips	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bleeding menstrual heavy	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bleeding nose	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bleeding nose	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Bleeding time abnormal	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Blepharitis	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Blister	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Blister of lip	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Blistering of mouth	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Blood albumin	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Blood alkaline phosphatase NOS decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Blood bilirubin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00017 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Blood creatinine decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Blood creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Blood in stool	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Blood in urine	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Blood phosphorus increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Blood stool	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Blood urea nitrogen decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Blood urea nitrogen increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected357 at risk EG0020 affected7 at risk
Bloodshot eye	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bloody semen	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Blurred vision	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00067 affected357 at risk EG00141 affected365 at risk EG0020 affected7 at risk
Body odor	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Boil	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bone density decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00053 affected357 at risk EG00152 affected365 at risk EG0020 affected7 at risk
Bone spur	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bowel cramps	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bowel movement irregularity	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bradycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG00029 affected357 at risk EG00124 affected365 at risk EG0020 affected7 at risk
Brain disorder NOS	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Breast discomfort	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Breast ductal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Breast lump	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Breast mass	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Breast pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Breast swelling	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Breast tenderness	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Breath shortness	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Breathing difficult	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Breathlessness	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Brittle nails	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Broken bones	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Broken foot	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bronchial infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Bronchiolitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bronchitis acute	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bronchitis asthmatic	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bronchitis viral	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Bruise	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Bruising	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG00018 affected357 at risk EG00131 affected365 at risk EG0020 affected7 at risk
Bruising of face	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Buccal ulceration	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Bug bite	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
BUN increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Burn	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Burn of face, unspecified degree	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Burning eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Burning leg	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Burning micturition	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Burning sensation in abdomen	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Burning tongue	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Bursitis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Buttock pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Calcium ionized	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Calcium low	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Calf pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Canker sore lip	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Canker sores oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Carbon monoxide diffusing capacity decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Carbuncle	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Carcinoma kidney	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cardiac arrest	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cardiac disorder	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Caregiver	Social circumstances	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Carpal tunnel syndrome	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Cataract	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Catheter infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Catheter placement	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Catheter site bleeding	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Catheter site bruise	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Catheter site erythema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Catheter site pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Catheter site redness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00116 affected365 at risk EG0020 affected7 at risk
Cellulitis of arm	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cellulitis of thumb	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cervical dysplasia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cervical pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chalazion	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cherry angiomas	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chest cold	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chest discomfort	General disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Chest fullness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Chest mass NOS	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chest pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG00031 affected357 at risk EG00158 affected365 at risk EG0020 affected7 at risk
Chest pain (non-cardiac)	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Chest tenderness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chest tightness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Chest wall abscess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Chills	General disorders	CTCAE (4.0)	Systematic Assessment	EG00033 affected357 at risk EG00148 affected365 at risk EG0021 affected7 at risk
Chloride	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Chloride high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Choking	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cholecystitis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Cholelithiasis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Cholesterol high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Chronic cholecystitis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chronic gastritis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Chronic heartburn	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chronic kidney disease	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Chronic lower extremity cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Chronic renal failure	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Circulating thrombus	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Clonus	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Clostridium difficile infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Cloudy urine	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Coccyalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cognitive deterioration	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cognitive disorder	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0016 affected365 at risk EG0021 affected7 at risk
Cold	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00038 affected357 at risk EG00141 affected365 at risk EG0020 affected7 at risk
Cold extremities	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cold feet	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cold intolerance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cold intolerance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cold sore (herpetic)	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cold sores	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Colic biliary	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Colitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Collapsed vertebra	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Colonic polyp	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Compression fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Concentration impaired	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0017 affected365 at risk EG0021 affected7 at risk
Conduction disorder	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Confusion	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Congestion nasal	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Congestive heart failure	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Conjunctival injection	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Conjunctivitis	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected357 at risk EG00114 affected365 at risk EG0020 affected7 at risk
Conjunctivitis bacterial	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Conjunctivitis infective	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Conjunctivitis, unspecified	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Constipation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG000192 affected357 at risk EG001196 affected365 at risk EG0021 affected7 at risk
Contact dermatitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Continuous urinary leakage	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Contusion of finger	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Contusion of foot	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Copper deficiency	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Coronary artery atherosclerosis	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Coronary artery disease	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Coronavirus infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Coronavirus test positive	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Correction hammer toe	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG000118 affected357 at risk EG001141 affected365 at risk EG0021 affected7 at risk
Cough nonproductive	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
CPK increase	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Crackling jaw	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cramps	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00044 affected357 at risk EG00147 affected365 at risk EG0020 affected7 at risk
Cramps in the calves	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Creatine urine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Creatinine increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG00024 affected357 at risk EG00125 affected365 at risk EG0021 affected7 at risk
Cryoglobulins	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cushingoid	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cyst	General disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Cyst removal	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Cystitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Cytopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Darkened skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Debridement	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Decreased activity	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Decreased appetite	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00018 affected357 at risk EG00121 affected365 at risk EG0020 affected7 at risk
Decreased INR	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Deep vein thrombosis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Deformity thorax	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Degenerative disc disease	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Dehydration	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00015 affected357 at risk EG00132 affected365 at risk EG0020 affected7 at risk
Delayed healing of wound	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Delirium	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Delusional perception	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Demyelinating polyneuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Dental abscess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Dental caries	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Dental cavity	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Dental disorder NOS	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Depression	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG00038 affected357 at risk EG00154 affected365 at risk EG0020 affected7 at risk
Dermatitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Dermatitis radiation	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Device related infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Diabetes	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Diaphoresis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Diaphragmatic disorder	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Diarrhea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG000192 affected357 at risk EG001233 affected365 at risk EG0020 affected7 at risk
Difficulty breathing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Difficulty in walking	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Diplopia	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Discoloration skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Dislocation of wrist	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Disorder equilibrium	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Disorder sperm	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Disorder tendon	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Disorder urinary tract	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Disorientation	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Distress gastrointestinal	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Diverticulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Dizziness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00073 affected357 at risk EG00191 affected365 at risk EG0021 affected7 at risk
Dog bite	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Drenching sweats	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
DRESS syndrome	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Drowsiness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Drug intolerance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Dry cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Dry eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00030 affected357 at risk EG00121 affected365 at risk EG0020 affected7 at risk
Dry heaves	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Dry lips	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Dry mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected357 at risk EG00130 affected365 at risk EG0020 affected7 at risk
Dry nose	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Dry skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00052 affected357 at risk EG00148 affected365 at risk EG0020 affected7 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Duodenal ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Dysesthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Dysgeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00051 affected357 at risk EG00152 affected365 at risk EG0020 affected7 at risk
Dysosmia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected357 at risk EG00137 affected365 at risk EG0020 affected7 at risk
Dysphasia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG000109 affected357 at risk EG00198 affected365 at risk EG0021 affected7 at risk
Dystonic reaction	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Dysuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Ear ache	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Ear congestion	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Ear discomfort	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Ear disorder	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Ear feels clogged	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Ear infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Ear pain	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00116 affected365 at risk EG0020 affected7 at risk
Ear ringing	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Ear swelling	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Ear wax	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Early satiety	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Eczema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG000157 affected357 at risk EG001143 affected365 at risk EG0020 affected7 at risk
Edema arms	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Edema face	General disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Edema knees	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Edema legs	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Edema of eyelid	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Ejection fraction decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Elbow deformity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Electric shock sensation	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Electrocardiogram QTc interval prolonged	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Electrolyte abnormality	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Elevated liver enzymes	Investigations	CTCAE (4.0)	Systematic Assessment	EG00054 affected357 at risk EG00156 affected365 at risk EG0021 affected7 at risk
Elevated prostate specific antigen [PSA]	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Emesis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Emesis bloody	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Emotional disorder	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Emotional distress	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0021 affected7 at risk
Emotional instability	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Emotional lability	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Empyema	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Enlarged prostate	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Enterocolitis infectious	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Enterovirus infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Eosinophilia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Epididymitis	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Epigastric discomfort	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Epigastric hernia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Erectile dysfunction	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Erythema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Erythema eyelid	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Erythropapular rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Esophageal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Esophageal stenosis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Esophageal ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Esophagitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG00124 affected365 at risk EG0020 affected7 at risk
Essential hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Exacerbation of asthma	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Exaggerated well-being	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Excess sweating	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Excessive thirst	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Exercise EKG abnormal	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Exercise tolerance decreased	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Exertional dyspnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Exposure to poison ivy	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Extensive rash of forearm	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
External ear infection NOS	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Extravasation	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Extremities burning sensation of	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Eye allergy	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Eye disorder	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Eye edema	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Eye floaters	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Eye infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Eye inflammation	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Eye injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Eye irrigation	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Eye irritation	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Eye itching	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Eye muscle weakness	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Eye pain	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Eye redness	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Eyelid abscess drainage	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Eyelid injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Eyelid irritation	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Eyelid margin crusting	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Eyelid twitching	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Eyelid twitching	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Eyes swollen	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Face injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Face rigidity	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Facial nerve disorder	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Facial pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Facial swelling	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Faint	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fall	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG00021 affected357 at risk EG00130 affected365 at risk EG0020 affected7 at risk
Fascitis plantar	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fatigue	General disorders	CTCAE (4.0)	Systematic Assessment	EG000230 affected357 at risk EG001235 affected365 at risk EG0022 affected7 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Fecal incontinence	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Feeling jittery	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Feeling of warmth	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Feeling strange	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Femur fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fever	General disorders	CTCAE (4.0)	Systematic Assessment	EG00096 affected357 at risk EG001113 affected365 at risk EG0022 affected7 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fibula fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fine motor delay	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Finger cramps	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Fingers stiffness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fingers swollen feeling of	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Flank pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Flashing lights	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Flatulence	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00123 affected365 at risk EG0020 affected7 at risk
Floaters	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Floaters in eye	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Flu like symptoms	General disorders	CTCAE (4.0)	Systematic Assessment	EG00041 affected357 at risk EG00143 affected365 at risk EG0020 affected7 at risk
Fluid in middle ear	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fluid overload	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Flu-like illness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Flu-like symptoms	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Flushing	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG0018 affected365 at risk EG0021 affected7 at risk
Foggy feeling in head	General disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Folic acid deficiency	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Folliculitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG00115 affected365 at risk EG0020 affected7 at risk
Food poisoning	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Foot cramps	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Foot discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Foot drop	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Foot edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Foot fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Foot injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Foot pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Foot sprain	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Forehead swelling	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Forgetfulness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fracture femur	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fracture of metacarpal bone(s)	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fracture of spine	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fracture vertebral	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fractured finger	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fractured metatarsal	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fractured radial head	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fractured ribs	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fractured thumb	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Fractured toe	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Fractured vertebra (compression)	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Frequent bowel movements	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Fungal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Fungal rash	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gait disorder	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gait disturbance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Gallbladder disease	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gallbladder pain	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Gallstones	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gastric ulcer	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gastritis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Gastritis erosive	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gastroenteritis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Gastroenteritis norovirus	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG00116 affected365 at risk EG0020 affected7 at risk
Gastrointestinal bleed	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Gastrointestinal discomfort	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Gastrointestinal disorder	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gastrointestinal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gastrointestinal mucositis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gastrointestinal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Gastrointestinal symptom NOS	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gastrointestinal viral infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Gastroparesis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Generalized illness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Genital abrasion	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Genital herpes	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Genital labial cyst	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Genital lesion	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Genital pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
GERD	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected357 at risk EG00117 affected365 at risk EG0020 affected7 at risk
GI infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
GI neoplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gingival hyperpigmentation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gingival pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gingivitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Glaucoma	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Glucose high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Glucose increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Goose bumps	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gout	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Gout flare	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gouty pain	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Graft versus host disease	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Granuloma faciale	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Grinding tooth	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Groin abscess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Groin discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Groin pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Gum bleeding	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Gum disorder	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Gum infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gum pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gum swelling	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Gynecomastia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Haemorrhoids	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hair breakage	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hair loss	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hallucinations	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hand fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hand osteoarthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hand pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hand swelling	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hands weakness of	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hashimoto's thyroiditis	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
HbA1C increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Head injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Head pain	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Head tightness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00087 affected357 at risk EG001116 affected365 at risk EG0021 affected7 at risk
Hearing disability	Social circumstances	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hearing impaired	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Heart enlarged	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Heart murmur	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0021 affected7 at risk
Heart rate high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Heart rate increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Heartburn	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00017 affected357 at risk EG00116 affected365 at risk EG0020 affected7 at risk
Heat intolerance	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Heat rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Heat sensitivity	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Heaviness in limbs	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Helicobacter pylori gastritis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Helicobacter pylori infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hematocrit increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hematoma	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Hematuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Hemoptysis	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hemorrhage oral	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hemorrhagic cystitis	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hemorrhoidal bleeding	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hemorrhoids	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Hemothorax	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hepatic lesion	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hepatic steatosis	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hepatitis C	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hepatosplenomegaly	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hernia	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hernia inguinal	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Herpes labialis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Herpes simplex	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Herpes zoster	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00114 affected365 at risk EG0020 affected7 at risk
Herpes zoster multi-dermatomal	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hiatal hernia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected357 at risk EG00118 affected365 at risk EG0020 affected7 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
High cholesterol	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hip discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hip fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hip surgery	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hirsutism	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hives	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected357 at risk EG00114 affected365 at risk EG0020 affected7 at risk
Hordeolum	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hot feeling in hand	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hot flashes	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG00020 affected357 at risk EG00127 affected365 at risk EG0020 affected7 at risk
Human anaplasmosis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Human papilloma virus infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hyperactivity	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hyperalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hyperbilirubinemia	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Hypercalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hyperchloremic acidosis	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hypercholesterolemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hyperglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00043 affected357 at risk EG00138 affected365 at risk EG0021 affected7 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hyperkalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Hyperlipasemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hyperlipidemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hypermagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Hypernatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Hyperopia	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hyperpigmentation skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hyperpigmentation skin	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hypersensation skin	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG00072 affected357 at risk EG00169 affected365 at risk EG0020 affected7 at risk
Hyperthyroidism	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hyperuricemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00017 affected357 at risk EG00118 affected365 at risk EG0020 affected7 at risk
Hypocalcemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00048 affected357 at risk EG00154 affected365 at risk EG0022 affected7 at risk
Hypogammaglobulinaemia	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hypogeusia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hypoglycemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00011 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Hypokalemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00085 affected357 at risk EG00192 affected365 at risk EG0021 affected7 at risk
Hypomagnesemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected357 at risk EG00136 affected365 at risk EG0020 affected7 at risk
Hyponatremia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00028 affected357 at risk EG00133 affected365 at risk EG0021 affected7 at risk
Hyponatremia aggravated	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hypophosphatemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG00062 affected357 at risk EG00149 affected365 at risk EG0020 affected7 at risk
Hypotension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG00030 affected357 at risk EG00147 affected365 at risk EG0021 affected7 at risk
Hypotension orthostatic	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Hypotensive	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hypothermia	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hypothyroidism	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Hypouricaemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Hypovolemia	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Hypoxemia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Ill-defined intestinal infections	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Impotence	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Incontinence	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Increased serum creatinine	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Increased stool urgency	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Increased thirst	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Increased urinary frequency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG00011 affected357 at risk EG00117 affected365 at risk EG0020 affected7 at risk
Indigestion	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Infected cyst	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Infected finger	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Infected thumb	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Infected toe	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Infection ingrowing toenail	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Infection localised	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Infection NOS	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Infection staphylococcal	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Inflammation	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Inflammation localized	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Influenza	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00014 affected357 at risk EG00117 affected365 at risk EG0020 affected7 at risk
Influenza B virus infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Infusion site extravasation	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Infusion site reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Ingrown toe nail	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Inguinal hernia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Injection site reaction	General disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Injection site tenderness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Injury to finger NOS	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Injury to kidney	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Injury to shoulder NOS	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
INR decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
INR increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Insect bite NOS	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG000136 affected357 at risk EG001126 affected365 at risk EG0020 affected7 at risk
Iron deficiency	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Irregular menstruation	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Irritability	General disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Irritable bowel syndrome	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Irritation gum	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Irritation lips	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Irritation of eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Itchy eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Itchy rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Itchy scalp	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Itchy throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Jaundice	Hepatobiliary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Jaw bone pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Jaw disorder	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Jaw movements disturbance	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Jaw pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00017 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Jitteriness	General disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Joint ache	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Joint edema	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Joint inflammation	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Keratosis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Kidney infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Kidney pain	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Kidney stones	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Knee derangement	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Knee injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Knee sprain	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Kyphoplasty	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lability emotional	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Labyrinthine disorders	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Labyrinthitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Laceration	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Laceration of arm	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Laceration of face	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Laceration of finger	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Laceration of foot	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Laceration of hand	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lactate dehydrogenase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Laryngeal erythema	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Laryngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lateral epicondylitis	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
LE rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Left lower quadrant pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Left otitis externa	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Left upper quadrant pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Leg cramps	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Leg edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Leg injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Leg ulcer	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lethargy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Leukocyte count NOS	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Leukocytosis	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Leukopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00050 affected357 at risk EG00167 affected365 at risk EG0021 affected7 at risk
Libido decreased	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Light headedness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00023 affected357 at risk EG00124 affected365 at risk EG0020 affected7 at risk
Light sensitivity to eye	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Light-headed	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Limbs stiffness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Lip basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lip infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lip injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lip sore	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lip ulceration	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lipase increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Liver function test abnormal	Investigations	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Localised muscle pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Localized rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Localized tingling	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Loose motions	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Loose stools	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00119 affected365 at risk EG0020 affected7 at risk
Loss of consciousness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Loss of eyelashes	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lower abdominal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lower extremities weakness of	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lower urinary tract symptoms	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lumbar disc degeneration	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lumbar pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lung nodule	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lyme disease	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lymph node pain	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lymph node palpable	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lymph nodes enlarged	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lymphadenitis	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Lymphadenopathy	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lymphedema	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lymphocytes	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Lymphopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00032 affected357 at risk EG00125 affected365 at risk EG0020 affected7 at risk
Macroglossia	Congenital, familial and genetic disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Macular hole	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Magnesium increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Malaise	General disorders	CTCAE (4.0)	Systematic Assessment	EG00026 affected357 at risk EG00120 affected365 at risk EG0020 affected7 at risk
Malar rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Malnutrition	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Mania	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mass	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mean cell volume low	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Melanocytic nevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Melena	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Memory impairment	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00025 affected357 at risk EG00127 affected365 at risk EG0020 affected7 at risk
Memory loss transient	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Meniscus rupture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Menorrhagia	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Mental concentration decreased	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Mental disorder NOS	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mental distress	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Mental impairment	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Mental status changes	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Micturition burning	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Migraine	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Mitral regurgitation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mitral valve incompetence	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mobitz type I	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mood change	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Morton's neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Motion sickness	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mouth cyst	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Mouth injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mouth ulceration	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Mucosal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Mucositis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00022 affected357 at risk EG00191 affected365 at risk EG0020 affected7 at risk
Mucus from eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Multiple allergies	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Muscle cramps	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00038 affected357 at risk EG00130 affected365 at risk EG0020 affected7 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Muscle spasm	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Muscle strain	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Muscle swelling	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Muscle tension	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected357 at risk EG00123 affected365 at risk EG0020 affected7 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00051 affected357 at risk EG00150 affected365 at risk EG0020 affected7 at risk
Mycosis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nail discoloration	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Nail disorder	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Nail fungal infection NOS	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nail infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nasal burning	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00052 affected357 at risk EG00159 affected365 at risk EG0020 affected7 at risk
Nasal cyst	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nasal irritation	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nasal mucosal inflammation	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nasal sinus congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nasal sinus drainage	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Nausea	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG000155 affected357 at risk EG001218 affected365 at risk EG0022 affected7 at risk
Neck discomfort	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Neck edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00026 affected357 at risk EG00137 affected365 at risk EG0020 affected7 at risk
Neck rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Neck strain	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Neck swelling	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0021 affected7 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nerve compression	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nerve pain	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Nervous system disorder	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Neuralgia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00052 affected357 at risk EG00140 affected365 at risk EG0020 affected7 at risk
Neutropenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00062 affected357 at risk EG00195 affected365 at risk EG0021 affected7 at risk
Nevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Night sweats	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00015 affected357 at risk EG00124 affected365 at risk EG0020 affected7 at risk
Nightmares	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nipple discharge	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nipple tenderness	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nocturia	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nocturia	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Nodular fasciitis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nodule	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Nodule on extremity	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Non ST segment elevation myocardial infarction	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Non-cardiac chest pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Norovirus test positive	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Nose infection NOS	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Nose injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Nosocomial pneumonia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Numbness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Numbness facial	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Numbness in face	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Numbness lips	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Numbness localised	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Numbness localised	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Numbness of extremities	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00115 affected365 at risk EG0020 affected7 at risk
Numbness of tongue	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Numbness of upper arm	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0021 affected7 at risk
Obstructive sleep apnea syndrome	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Oedema trunk	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Optic neuritis	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Oral candidiasis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Oral dysesthesia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Oral hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Oral infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Oral intake reduced	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Oral lesion	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Oral mucosal erythema	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
oral pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Orbital cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Organizing pneumonia	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Orthopnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Orthostatic hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00012 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Otitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Otitis externa	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Otitis media	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Otitis media	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Overgrowth bacterial	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG000109 affected357 at risk EG001105 affected365 at risk EG0021 affected7 at risk
Pain abdominal	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain back	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain bone	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain flank	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain foot	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Pain foot	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain groin	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pain in ankle	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Pain in arm	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Pain in elbow	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00036 affected357 at risk EG00133 affected365 at risk EG0020 affected7 at risk
Pain in face	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain in fingers	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pain in hand	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain in hip	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00048 affected357 at risk EG00132 affected365 at risk EG0020 affected7 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pain in joint	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pain in leg	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00020 affected357 at risk EG00121 affected365 at risk EG0020 affected7 at risk
Pain in legs	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00017 affected357 at risk EG00124 affected365 at risk EG0020 affected7 at risk
Pain in muscle	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00012 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Pain in Neck	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Pain in shoulder	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00040 affected357 at risk EG00149 affected365 at risk EG0020 affected7 at risk
Pain in tongue	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain in tooth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00014 affected357 at risk EG00115 affected365 at risk EG0020 affected7 at risk
Pain in upper extremities	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Pain in wrist	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Pain joint	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Pain knee	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00019 affected357 at risk EG00117 affected365 at risk EG0020 affected7 at risk
Pain localized	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Pain lower ribs	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pain NOS	General disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Pain sacroiliac	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Painful L arm	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Painful urination	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pains in legs	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pallor	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Palmar erythema	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Palpitations	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Pancytopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Panic attack	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Papule	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Papulopustular rash	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Paraesthesia hand	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Paresthesia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00054 affected357 at risk EG00142 affected365 at risk EG0020 affected7 at risk
Paresthesia hand	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Paresthesia of genital female	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Paresthesia upper limb	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Parkinson's disease	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Paronychia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Parotid gland inflammation	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Parotiditis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Parotitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Paroxysmal atrial fibrillation	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pelvic congestion syndrome	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pelvic pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Penetrating abdominal trauma	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Penis injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Perforation of tympanic membrane	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Perianal bleeding	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Periapical abscess without sinus	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pericardial effusion	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pericarditis	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Periodontal disease	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Perioral numbness	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Periorbital cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Periorbital edema	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Perirectal abscess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Periumbilical pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Petechiae	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Peyronie's disease	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pharyngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Phlebitis superficial	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Phlegm	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Phosphate decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Phosphorus low	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Photophobia	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Pinkeye	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Plantar warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Plasma cell leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Pneumonia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00038 affected357 at risk EG00158 affected365 at risk EG0020 affected7 at risk
Poison ivy rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Poison oak rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Polyp	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Polyuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Popliteal cyst	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Post herpetic neuralgia	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Postnasal drip	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00120 affected365 at risk EG0020 affected7 at risk
Postoperative ileus	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Premenstrual dysphoric disorder	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Presyncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Proctocolitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Prostatitis	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Protein-calorie malnutrition	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Proteins serum plasma low	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Proteinuria	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Prothrombin increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Prothrombin time increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Proximal myopathy	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pruritis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00025 affected357 at risk EG00140 affected365 at risk EG0020 affected7 at risk
Pseudogout	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pseudoseizure	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Psoriasis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Psoriatic arthritis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Psychomotor development impaired	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Psychotic episode	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
PTH increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pulled muscle	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pulmonary embolism	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pulmonary infiltration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Puncture wound	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Purpura	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Pyelonephritis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pyogenic granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Pyrexia	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Pyrosis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
QT interval prolonged	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Radiculitis	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Radiculopathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Rash face	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rash face	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Rash follicular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG000113 affected357 at risk EG001126 affected365 at risk EG0021 affected7 at risk
Rash over arms	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Rash scaly	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Reactive airways disease	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rectal bleeding	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Rectal blood loss	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rectal fissure	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rectal hemorrhage	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rectal pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Red eye	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Renal calculi	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Renal colic	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Renal disease	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Renal function aggravated	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Renal function decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Renal impairment	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Renal insufficiency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Renal tract inflammation	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Respiratory syncytial virus infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Resting tremor	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Restless leg syndrome	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Restlessness	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Retinal atrophy	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Retinal telangiectasia	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Retro-orbital pain	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rhinitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Rhinitis infective	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00019 affected357 at risk EG00121 affected365 at risk EG0020 affected7 at risk
Rhinovirus infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Rhinovirus infection NOS	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Rib fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Rib injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rib pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG00021 affected357 at risk EG00124 affected365 at risk EG0020 affected7 at risk
Right upper quadrant pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rigors	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Ringing in ears	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Ringworm NOS	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Root canal procedure	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Rosacea	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Rotator cuff injury	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Rotator cuff repair	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Rotator cuff tear	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Sacral edema	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sacral pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Salivary hypersecretion	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scab	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scabbing	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Scabies	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scalp disorder	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Scalp laceration	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scalp pain	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scalp plaque	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Scapula pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sciatica	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Scleral haemorrhage	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scratch	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scrotal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scrotal pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Scrotal swelling	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Seasonal allergy	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Sebaceous cyst	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Seborrhea capitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Seborrheic dermatitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Seborrheic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Second primary malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Second rib fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Seizure	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sensation of heaviness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sensation of pressure in ear	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sensitivity of teeth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Sensory neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sensory peripheral neuropathy	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG000247 affected357 at risk EG001232 affected365 at risk EG0020 affected7 at risk
Sepsis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Septic shock	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Serum ferritin abnormal	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sexual dysfunction	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
SGPT increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Shin splints	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Shingles	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Shoulder blade pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Shoulder deformity	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sinus bradycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG00019 affected357 at risk EG00114 affected365 at risk EG0020 affected7 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0007 affected357 at risk EG00123 affected365 at risk EG0020 affected7 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Sinus headache	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sinus infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Sinus pain	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Sinus tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Sinusitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00029 affected357 at risk EG00142 affected365 at risk EG0021 affected7 at risk
Skin abrasion	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Skin biopsy	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Skin bleeding	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin cold clammy	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin disorder	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin dry	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin fissures	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00012 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Skin irritation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Skin lesion	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Skin peeling	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin peeling	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Skin pigmentation	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin rash	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Skin scaly	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin seborrheic	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Skin sensitization	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin sensitization	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Skin striae	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin swelling	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Skin tear	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Skin tenderness	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sleep disorder	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Sleep disturbance	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sleep walking	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sleepiness	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Slight temperature	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Slurred speech	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Small bowel obstruction	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Small intestinal obstruction	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Smell alteration	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sodium high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sodium low	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Soft stools	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Soft tissue infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Soft tissue mass	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Solar dermatitis	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Somnolence	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sore feet	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sore mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected357 at risk EG00149 affected365 at risk EG0020 affected7 at risk
Spasms	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Spasticity	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Specific allergy (drug)	Immune system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Spider bite	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Spinal fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Splinter	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sporotrichosis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Spotting menstrual	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Spotting vaginal	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Sprained ankle	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Sputum abnormal	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Sputum bloody	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG00012 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Staphylococcal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Sternal pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sternal pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Sticky feeling in eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Stiff back	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Stiff neck	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Stiffness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Stiffness hip	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Stiffness shoulder	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Stomach ache	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Stomach flu	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Stomach pain	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00069 affected357 at risk EG00172 affected365 at risk EG0020 affected7 at risk
Stomach virus	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Stomachache	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Stomatitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Strain	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Streptococcal sore throat	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Stress	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Stress fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Stroke	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Stye	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00022 affected357 at risk EG00111 affected365 at risk EG0020 affected7 at risk
Subconjunctival hemorrhage	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Subconjunctival hemorrhage	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Subcutaneous nodule	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Subdural hematoma	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Submaxillary gland swelling	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Suicidal ideation	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Sun spots	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sunburn	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Superficial thrombophlebitis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Superficial thrombosis of veins	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Suprapubic pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Supraspinatus syndrome	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Surgical procedure	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Suture insertion	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Swallowing difficult	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Sweating	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sweating	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Sweating and Sweaty	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Sweating and Sweaty	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0019 affected365 at risk EG0020 affected7 at risk
Sweating increased	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Swelling of knees	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Swelling of L knee	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Swelling of R knee	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Swelling of tongue	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Swollen glands	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Swollen lymph nodes	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Swollen thumb	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Syncope	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0008 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Syphilis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Systolic murmur	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tachycardia	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG00010 affected357 at risk EG00128 affected365 at risk EG0020 affected7 at risk
Tachypnea	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Taste alteration	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Taste diminished	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Teary eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0005 affected357 at risk EG0019 affected365 at risk EG0021 affected7 at risk
Temporomandibular joint disorder	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tenderness	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Tendinitis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Tennis elbow	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tension headaches	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Testicular disorder	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Testicular edema	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Testicular pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Testis discomfort	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Testosterone low	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Thirst	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Thoracic spondylosis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Throat infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Throat pain	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Thrombocytopenia	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG00040 affected357 at risk EG00184 affected365 at risk EG0022 affected7 at risk
Thrombocytosis	Blood and lymphatic system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Thromboembolic event	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG00121 affected365 at risk EG0020 affected7 at risk
Thrombosis	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Thrush	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG00113 affected365 at risk EG0020 affected7 at risk
Thyroid cyst	Endocrine disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Thyroid hot nodule	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Thyroid nodular	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Thyroid nodule	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Thyroid nodule	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Thyroid stimulating hormone increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tibia pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Tick bite	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Tightness of back muscles	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tinea capitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tinea corporis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tinea cruris	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tinea pedis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Tingling lips	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tingling skin	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tinnitus	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG00018 affected357 at risk EG00114 affected365 at risk EG0020 affected7 at risk
Tired eyes	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Toe injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Tongue blistering	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tongue disorder	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tongue edema	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tongue infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tongue injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tongue swelling non-specific	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tongue ulceration	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Tonsillitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tooth abscess	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Tooth ache	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Tooth extraction	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Tooth fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Tooth infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tooth infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Tooth injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tooth injury	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Torn muscle	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Torticollis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Tracheal inflammation	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Transaminases increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Transaminitis	Investigations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Transfusion reaction	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Transient insomnia	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Transient ischemic attacks	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Tremor	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG00034 affected357 at risk EG00132 affected365 at risk EG0020 affected7 at risk
Trigeminy	Cardiac disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Triglycerides	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Trochanteric bursitis	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
TSH increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Twitching	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Ulcer mouth	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Ulceration of intestine	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Umbilical hernia	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Uncontrolled hypertension	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Unilateral leg pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Unspecified disease of hair and hair follicles	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Upper back pain	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Upper respiratory infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG000165 affected357 at risk EG001180 affected365 at risk EG0020 affected7 at risk
Upset stomach	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Urethral burning on micturition	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Urgency urination	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Uric acid decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Uric acid high	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Uric acid increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Urinary hesitancy	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Urinary incontinence	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Urinary infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Urinary obstruction unspecified	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Urinary output diminished	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Urinary retention	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Urinary tract infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG00026 affected357 at risk EG00132 affected365 at risk EG0020 affected7 at risk
Urinary tract infection bacterial	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Urinary tract pain	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Urinary urgency	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0018 affected365 at risk EG0020 affected7 at risk
Urination difficulty	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Urination frequency of	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Urination pain	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Urine color abnormal	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Urine discoloration	Renal and urinary disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Urine output decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Urticaria	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Urticaria localised	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Uterine bleeding	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Uterine fibroid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Uveitis	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Uvulitis	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vaginal bleeding	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Vaginal cyst	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vaginal discomfort	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vaginal dryness	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Vaginal infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0015 affected365 at risk EG0020 affected7 at risk
Vaginal inflammation	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vaginal irritation	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vaginal itching	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0016 affected365 at risk EG0020 affected7 at risk
Vaginal lesion	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vaginal pain	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Varicose vein	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Varicosity	Vascular disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vascular access complication	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Venipuncture site pain	General disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Venous ulcer NOS	Skin and subcutaneous tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Verruca	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vertigo	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG00017 affected357 at risk EG00110 affected365 at risk EG0020 affected7 at risk
Vestibular disorder	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Viral gastroenteritis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Viral infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0006 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk
Viral laryngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Viral meningitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Viral pharyngitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Viral pneumonia	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0013 affected365 at risk EG0020 affected7 at risk
Viral syndrome	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Viral upper respiratory tract infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vision abnormal	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0014 affected365 at risk EG0020 affected7 at risk
Vision double	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vision loss	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Visual discomfort	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Visual disturbances	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vitamin D decreased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	CTCAE (4.0)	Systematic Assessment	EG0004 affected357 at risk EG00112 affected365 at risk EG0020 affected7 at risk
Vitreous detachment	Eye disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vivid dreams	Psychiatric disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vocal cord nodule	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Voice alteration	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Vomiting	Gastrointestinal disorders	CTCAE (4.0)	Systematic Assessment	EG00064 affected357 at risk EG001127 affected365 at risk EG0022 affected7 at risk
Vulval lesion	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Vulvovaginal atrophy	Reproductive system and breast disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Wart	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Wax in ear	Ear and labyrinth disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Weakness	General disorders	CTCAE (4.0)	Systematic Assessment	EG00013 affected357 at risk EG00121 affected365 at risk EG0020 affected7 at risk
Weakness left or right side	Nervous system disorders	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0011 affected365 at risk EG0020 affected7 at risk
Weakness of arms	Musculoskeletal and connective tissue disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Weight gain	Investigations	CTCAE (4.0)	Systematic Assessment	EG00030 affected357 at risk EG00121 affected365 at risk EG0020 affected7 at risk
Weight loss	Investigations	CTCAE (4.0)	Systematic Assessment	EG00034 affected357 at risk EG00128 affected365 at risk EG0020 affected7 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0009 affected357 at risk EG00114 affected365 at risk EG0020 affected7 at risk
White blood cell count increased	Investigations	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Wound	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected357 at risk EG0012 affected365 at risk EG0020 affected7 at risk
Wound breakdown	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Wound drainage	Surgical and medical procedures	CTCAE (4.0)	Systematic Assessment	EG0002 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Wound infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Wrist fracture	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected357 at risk EG0010 affected365 at risk EG0020 affected7 at risk
Yeast infection	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0003 affected357 at risk EG0017 affected365 at risk EG0020 affected7 at risk

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D001896	Boron Compounds
D011719	Pyrazines
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds
D013514	Surgical Procedures, Operative

All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study.

After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant.

RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D000077269	Lenalidomide
D000069286	Bortezomib
D003907	Dexamethasone
D002123	Calcium Dobesilate
D014180	Transplantation