Combined Rituximab and Lenalidomide Treatment for Untreat... | NCT01476787

ID	Type	Description	Link
2011-002792-42	EudraCT Number

Name	Class
The Lymphoma Academic Research Organisation	OTHER

Label	Type	Description	Intervention Names
Lenalidomide + Rituximab	Experimental	Lenalidomide dose 20-mg on days 2-22 every 28 days for 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for up to 18 cycles. Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.	Drug: Rituximab Drug: Lenalidomide
Control	Active Comparator	• ONE of the following: Rituximab-CHOP, Rituximab-CVP, Rituximab-Bendamustine. 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.	Drug: Rituximab-CHOP Drug: Rituximab-CVP Drug: Rituximab-Bendamustine

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug	375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Measure	Description	Time Frame
Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review	The Complete Response Rate (CR/CRu) is the percentage of participants who achieve complete response (CR/CRu) at 120 weeks as assessed per Independent Central Review. Complete Response (CR): Disappearance of all evidence of disease. Complete Response Unconfirmed (CRu): Disappearance of all disease with the exception of residual lymph nodes that are 1.5 cm or less in greatest transverse diameter and/or indeterminate bone marrow findings.	At 120 weeks
Progression-free Survival (PFS)	Progression-free survival (PFS) is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause. Progressive Disease (PD) is characterized by any of the following: An increase of at least 50% in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal lymph node(s) or other disease sites. The appearance of any new lesion during or after treatment. An increase of at least 50% in the longest diameter of a previously identified node that was 1 cm or more in its short axis. An increase of at least 50% in the size of other lesions (e.g., splenomegaly, hepatomegaly). Based on Kaplan-Meier estimates.	From randomization into the study to the first observation of documented disease progression or death due to any cause (up to approximately 140 months).

Measure	Description	Time Frame
Complete Response Rate (CR) at 120 Weeks Per Independent Central Review	The Complete Response Rate (CR) is the percentage of participants who achieve confirmed complete response (CR) at 120 weeks as assessed per Independent Central Review. - Complete Response (CR): Disappearance of all evidence of disease.	At 120 weeks

Name	Affiliation	Role
Franck Morschhauser, MD, PhD	The Lymphoma Study Association (LYSA)	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 54103		Chandler	Arizona	85224	United States
Local Institution - 51803

PubMed Identifier	Type	Citation	Retractions
30184451	Background	Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.
25439689

Label	URL
BMS Clinical Trial Information	View source

ID	Title	Description
FG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.
FG001	Investigator Choice

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 8, 2024

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

Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review

The Complete Response Rate (CR/CRu) is the percentage of participants who achieve complete response (CR/CRu) at 120 weeks as assessed per Independent Central Review.

Complete Response (CR): Disappearance of all evidence of disease.
Complete Response Unconfirmed (CRu): Disappearance of all disease with the exception of residual lymph nodes that are 1.5 cm or less in greatest transverse diameter and/or indeterminate bone marrow findings.

All randomized participants

Posted

Number

95% Confidence Interval

Percent of participants

At 120 weeks

ID	Title	Description
OG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.
OG001	Investigator Choice	Rituximab-CHOP: with six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m^2 rituximab and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-CVP: with eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-Bendamustine: with rituximab 375 mg/m^2 (day 1) plus bendamustine 90 mg/m^2 (days 1 + 2) every 28 days for six cycles; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.

Units	Counts
Participants	OG000513 OG001517

Title

Denominators

Categories

Title	Measurements
	OG00048.1(43.7 to 52.6) OG00153.0(48.6 to 57.4)

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		Cochran-Mantel-Haenszel		0.128														Superiority

Primary

Progression-free Survival (PFS)

Progression-free survival (PFS) is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause.

Progressive Disease (PD) is characterized by any of the following:

An increase of at least 50% in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal lymph node(s) or other disease sites.
The appearance of any new lesion during or after treatment.
An increase of at least 50% in the longest diameter of a previously identified node that was 1 cm or more in its short axis.
An increase of at least 50% in the size of other lesions (e.g., splenomegaly, hepatomegaly).

Based on Kaplan-Meier estimates.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization into the study to the first observation of documented disease progression or death due to any cause (up to approximately 140 months).

ID	Title	Description
OG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.
OG001	Investigator Choice	Rituximab-CHOP: with six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m^2 rituximab and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-CVP: with eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-Bendamustine: with rituximab 375 mg/m^2 (day 1) plus bendamustine 90 mg/m^2 (days 1 + 2) every 28 days for six cycles; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.

Secondary

Complete Response Rate (CR) at 120 Weeks Per Independent Central Review

The Complete Response Rate (CR) is the percentage of participants who achieve confirmed complete response (CR) at 120 weeks as assessed per Independent Central Review.

- Complete Response (CR): Disappearance of all evidence of disease.

All randomized participants

Posted

Number

95% Confidence Interval

Percent of participants

At 120 weeks

ID	Title	Description
OG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.
OG001	Investigator Choice	Rituximab-CHOP: with six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m^2 rituximab and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-CVP: with eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-Bendamustine: with rituximab 375 mg/m^2 (day 1) plus bendamustine 90 mg/m^2 (days 1 + 2) every 28 days for six cycles; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.

Secondary

Event-free Survival (EFS)

Event Free Survival (EFS) is defined as the time a participant remains free from certain negative events (disease progression, relapse, initiation of a new anti-lymphoma treatment, or death) between the date of randomization to the date of first documented progression, relapse, and initiation of a new anti-lymphoma treatment or death by any cause. Responding participants and those lost to follow up were censored at their last tumor assessment date.

Progressive Disease (PD) is characterized by any of the following:

An increase of at least 50% in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal lymph node(s) or other disease sites.
The appearance of any new lesion during or after treatment.
An increase of at least 50% in the longest diameter of a previously identified node that was 1 cm or more in its short axis.
An increase of at least 50% in the size of other lesions (e.g., splenomegaly, hepatomegaly).

Based on Kaplan-Meier estimates.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of first documented progression, relapse, and initiation of a new anti-lymphoma treatment or death by any cause (up to approximately 140 months).

ID	Title	Description
OG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.
OG001

Secondary

Overall Survival (OS)

Overall survival (OS) is defined as the median length of time a participant stays alive from randomization. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who withdrew consent for the study were considered censored at the time of withdrawal. Participants who completed the study and were still alive at the time of the clinical data cut-off date were censored. All participants who were lost to follow-up prior to the clinical data cut-off date were also considered censored at the time of last contact. Based on Kaplan-Meier estimates.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From randomization to the date of death by any cause (up to approximately 144 months).

ID	Title	Description
OG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.
OG001	Investigator Choice	Rituximab-CHOP: with six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m^2 rituximab and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-CVP: with eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-Bendamustine: with rituximab 375 mg/m^2 (day 1) plus bendamustine 90 mg/m^2 (days 1 + 2) every 28 days for six cycles; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.

Secondary

Time to Next Anti-Lymphoma Treatment (TTNLT)

Time to Next Lymphoma Treatment (TTNLT) was measured from the date of randomization to the date of the first documented administration of any new anti-lymphoma treatment (such as chemotherapy, radiotherapy, radio-immunotherapy, or immunotherapy). Participants who continued to respond to treatment or who were lost to follow-up were considered censored on their last visit date. Participants who died (due to any cause) before receiving a new anti-lymphoma treatment were included in the statistical analysis, with death being counted as an event. Based on Kaplan-Meier estimates.

All randomized participants

Posted

Median

95% Confidence Interval

Months

From the date of randomization to the date of the first documented administration of any new anti-lymphoma treatment (up to approximately 140 months).

ID	Title	Description
OG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.
OG001	Investigator Choice	Rituximab-CHOP: with six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m^2 rituximab and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-CVP: with eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-Bendamustine: with rituximab 375 mg/m^2 (day 1) plus bendamustine 90 mg/m^2 (days 1 + 2) every 28 days for six cycles; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
AGRANULOCYTOSIS	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG0030 affected112 at risk
EOSINOPHILIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
FEBRILE BONE MARROW APLASIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0013 affected365 at risk EG0020 affected26 at risk EG003
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0009 affected507 at risk EG00117 affected365 at risk EG0021 affected26 at risk EG003
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0003 affected507 at risk EG0013 affected365 at risk EG0020 affected26 at risk EG003
PANCYTOPENIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0003 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ACUTE CORONARY SYNDROME	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ANGINA PECTORIS	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
AORTIC VALVE INCOMPETENCE	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ARRHYTHMIA	Cardiac disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	27.0	Systematic Assessment	EG0003 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ATRIAL FLUTTER	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BRADYCARDIA	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CARDIAC ARREST	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CARDIAC FAILURE	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
CARDIOMYOPATHY	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CARDIORENAL SYNDROME	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CARDIOTOXICITY	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CORONARY ARTERY STENOSIS	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PALPITATIONS	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PERICARDIAL EFFUSION	Cardiac disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SINUS NODE DYSFUNCTION	Cardiac disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
BRUGADA SYNDROME	Congenital, familial and genetic disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
GASTROINTESTINAL MALFORMATION	Congenital, familial and genetic disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
VERTIGO	Ear and labyrinth disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPERTHYROIDISM	Endocrine disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CATARACT	Eye disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PAPILLOEDEMA	Eye disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
RETINAL DETACHMENT	Eye disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0013 affected365 at risk EG0020 affected26 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ASCITES	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
COLITIS	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
COLITIS ISCHAEMIC	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CONSTIPATION	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0013 affected365 at risk EG0020 affected26 at risk EG003
DIARRHOEA	Gastrointestinal disorders	27.0	Systematic Assessment	EG0004 affected507 at risk EG0013 affected365 at risk EG0020 affected26 at risk EG003
DIVERTICULUM INTESTINAL	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ENTEROCOLITIS	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
FAECALOMA	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
GASTRITIS	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
GASTROINTESTINAL PAIN	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
HERNIAL EVENTRATION	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0021 affected26 at risk EG003
NAUSEA	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0013 affected365 at risk EG0020 affected26 at risk EG003
OESOPHAGITIS	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PANCREATITIS	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PANCREATITIS ACUTE	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
POOR DENTAL CONDITION	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
SUBILEUS	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
VOMITING	Gastrointestinal disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
ADVERSE DRUG REACTION	General disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ASTHENIA	General disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CARDIAC DEATH	General disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CHEST PAIN	General disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0012 affected365 at risk EG0021 affected26 at risk EG003
FACE OEDEMA	General disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
FATIGUE	General disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
FOREIGN BODY REACTION	General disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	27.0	Systematic Assessment	EG0004 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPERTHERMIA	General disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
MALAISE	General disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
MUCOSAL INFLAMMATION	General disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
OEDEMA PERIPHERAL	General disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
PYREXIA	General disorders	27.0	Systematic Assessment	EG00013 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
STRANGULATED HERNIA	General disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
BILIARY DILATATION	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BILIARY OBSTRUCTION	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CHOLANGITIS ACUTE	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HEPATITIS	Hepatobiliary disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
PORTAL VEIN THROMBOSIS	Hepatobiliary disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ANAPHYLACTIC REACTION	Immune system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ANAPHYLACTIC SHOCK	Immune system disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ANAPHYLACTOID REACTION	Immune system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
DRUG HYPERSENSITIVITY	Immune system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPERSENSITIVITY	Immune system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
APPENDICITIS	Infections and infestations	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BACTERIAL SEPSIS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BACTERIURIA	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BRONCHIOLITIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
BRONCHITIS	Infections and infestations	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CAMPYLOBACTER SEPSIS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CELLULITIS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
DEVICE RELATED SEPSIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ENTEROBACTER SEPSIS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ERYSIPELAS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ESCHERICHIA SEPSIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
FUSOBACTERIUM INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
GANGRENE	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
GASTROENTERITIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
GASTROENTERITIS VIRAL	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
GENITAL HERPES SIMPLEX	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
H1N1 INFLUENZA	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HEPATITIS E	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HERPES OPHTHALMIC	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
HERPES ZOSTER	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
HUMAN EHRLICHIOSIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
INFLUENZA	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0012 affected365 at risk EG0021 affected26 at risk EG003
LARGE INTESTINE INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0021 affected26 at risk EG003
MENINGITIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
OESOPHAGEAL CANDIDIASIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
PARONYCHIA	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PERITONITIS	Infections and infestations	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PHARYNGITIS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PILONIDAL DISEASE	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
PNEUMONIA	Infections and infestations	27.0	Systematic Assessment	EG00011 affected507 at risk EG0016 affected365 at risk EG0020 affected26 at risk EG003
PNEUMONIA HAEMOPHILUS	Infections and infestations	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PNEUMONIA STAPHYLOCOCCAL	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PNEUMONIA STREPTOCOCCAL	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
PNEUMONIA VIRAL	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PSEUDOMONAL SEPSIS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PSEUDOMONAS INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PYELONEPHRITIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
PYELONEPHRITIS ACUTE	Infections and infestations	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
SEPSIS	Infections and infestations	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
SEPTIC SHOCK	Infections and infestations	27.0	Systematic Assessment	EG0002 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
SINUSITIS	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
SOFT TISSUE INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
TONSILLITIS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
TOOTH ABSCESS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0005 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
URINARY TRACT INFECTION ENTEROCOCCAL	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
UROSEPSIS	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
VIRAL INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
WOUND INFECTION BACTERIAL	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
AORTIC INJURY	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CHEST INJURY	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
FALL	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
FEMUR FRACTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HAND FRACTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HIP FRACTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HUMERUS FRACTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
INCISIONAL HERNIA	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0009 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
MULTIPLE INJURIES	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
POSTOPERATIVE WOUND COMPLICATION	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
RADIUS FRACTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SPINAL COLUMN INJURY	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
SPINAL FRACTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ULNA FRACTURE	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ELECTROCARDIOGRAM T WAVE INVERSION	Investigations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
FIBRIN D DIMER INCREASED	Investigations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
TROPONIN INCREASED	Investigations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
TROPONIN T INCREASED	Investigations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
URINE OUTPUT DECREASED	Investigations	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
WEIGHT DECREASED	Investigations	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPERCALCAEMIA	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
MALNUTRITION	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0003 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0003 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
CHONDROCALCINOSIS	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
FLANK PAIN	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
OSTEONECROSIS OF JAW	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SOFT TISSUE NECROSIS	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
SPONDYLITIS	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ACUTE LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0004 affected507 at risk EG0015 affected365 at risk EG0020 affected26 at risk EG003
BENIGN NEOPLASM OF EPIDIDYMIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BENIGN RENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
BOWEN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CLEAR CELL RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
COLORECTAL ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
ENDOMETRIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
GALLBLADDER ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
INVASIVE DUCTAL BREAST CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
KERATOACANTHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
LARYNGEAL SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
LUNG SQUAMOUS CELL CARCINOMA STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
LYMPHOPROLIFERATIVE DISORDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
MENINGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
MENINGIOMA BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PAPILLARY THYROID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
RECTAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SMALL CELL LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SQUAMOUS CELL CARCINOMA OF LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0004 affected507 at risk EG0011 affected365 at risk EG0021 affected26 at risk EG003
SQUAMOUS CELL CARCINOMA OF THE CERVIX	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SQUAMOUS CELL CARCINOMA OF THE TONGUE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
TUMOUR FLARE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0005 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CARPAL TUNNEL SYNDROME	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	27.0	Systematic Assessment	EG0003 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HEADACHE	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
MIGRAINE WITH AURA	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
OPTIC NEURITIS	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SCIATICA	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
SEIZURE	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SPEECH DISORDER	Nervous system disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SYNCOPE	Nervous system disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0021 affected26 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
DEVICE BREAKAGE	Product Issues	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BIPOLAR DISORDER	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CONVERSION DISORDER	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
DEPRESSION	Psychiatric disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
MANIA	Psychiatric disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	27.0	Systematic Assessment	EG0003 affected507 at risk EG0012 affected365 at risk EG0021 affected26 at risk EG003
CALCULUS URINARY	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
HAEMATURIA	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYDRONEPHROSIS	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
POLLAKIURIA	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
RENAL FAILURE	Renal and urinary disorders	27.0	Systematic Assessment	EG0005 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
RENAL TUBULAR NECROSIS	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
URINARY RETENTION	Renal and urinary disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CYSTOCELE	Reproductive system and breast disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PENILE ADHESION	Reproductive system and breast disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PROSTATITIS	Reproductive system and breast disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
BRONCHOPNEUMOPATHY	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
LARYNGEAL OEDEMA	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0021 affected26 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0009 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0005 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
CAPILLARITIS	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
CUTANEOUS VASCULITIS	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ECZEMA	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
HYPERSENSITIVITY VASCULITIS	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
NEUTROPHILIC DERMATOSIS	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0021 affected26 at risk EG003
RASH	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00010 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
RASH PAPULAR	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
STEVENS-JOHNSON SYNDROME	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
TOXIC SKIN ERUPTION	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0003 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
URTICARIA	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
VASCULAR PURPURA	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
UMBILICAL HERNIA REPAIR	Surgical and medical procedures	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
AORTIC ANEURYSM RUPTURE	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
AORTIC DISSECTION	Vascular disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ARTERIAL THROMBOSIS	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ARTERIOVENOUS FISTULA	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ARTERITIS	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
BLEEDING VARICOSE VEIN	Vascular disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0011 affected365 at risk EG0020 affected26 at risk EG003
HAEMATOMA	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPERTENSION	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
HYPOTENSION	Vascular disorders	27.0	Systematic Assessment	EG0000 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
ORTHOSTATIC HYPOTENSION	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
PHLEBITIS	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0012 affected365 at risk EG0020 affected26 at risk EG003
PHLEBITIS SUPERFICIAL	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
SUPERFICIAL VEIN THROMBOSIS	Vascular disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
THROMBOSIS	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003
VASCULITIS	Vascular disorders	27.0	Systematic Assessment	EG0001 affected507 at risk EG0010 affected365 at risk EG0020 affected26 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG00025 affected507 at risk EG00144 affected365 at risk EG0023 affected26 at risk EG0038 affected112 at risk
LEUKOPENIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG00022 affected507 at risk EG00147 affected365 at risk EG0022 affected26 at risk EG003
LYMPHOPENIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0007 affected507 at risk EG00119 affected365 at risk EG0021 affected26 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG000199 affected507 at risk EG001172 affected365 at risk EG0027 affected26 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG00017 affected507 at risk EG00114 affected365 at risk EG0020 affected26 at risk EG003
PALPITATIONS	Cardiac disorders	27.0	Systematic Assessment	EG0007 affected507 at risk EG0019 affected365 at risk EG0020 affected26 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	27.0	Systematic Assessment	EG00077 affected507 at risk EG00129 affected365 at risk EG0022 affected26 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	27.0	Systematic Assessment	EG00037 affected507 at risk EG00145 affected365 at risk EG0021 affected26 at risk EG003
CONSTIPATION	Gastrointestinal disorders	27.0	Systematic Assessment	EG000179 affected507 at risk EG001109 affected365 at risk EG00213 affected26 at risk EG003
DIARRHOEA	Gastrointestinal disorders	27.0	Systematic Assessment	EG000184 affected507 at risk EG00150 affected365 at risk EG0026 affected26 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	27.0	Systematic Assessment	EG00026 affected507 at risk EG00119 affected365 at risk EG0022 affected26 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	27.0	Systematic Assessment	EG00018 affected507 at risk EG00115 affected365 at risk EG0020 affected26 at risk EG003
NAUSEA	Gastrointestinal disorders	27.0	Systematic Assessment	EG000100 affected507 at risk EG001128 affected365 at risk EG0027 affected26 at risk EG003
STOMATITIS	Gastrointestinal disorders	27.0	Systematic Assessment	EG00015 affected507 at risk EG00126 affected365 at risk EG0021 affected26 at risk EG003
VOMITING	Gastrointestinal disorders	27.0	Systematic Assessment	EG00032 affected507 at risk EG00161 affected365 at risk EG0022 affected26 at risk EG003
ASTHENIA	General disorders	27.0	Systematic Assessment	EG000144 affected507 at risk EG001129 affected365 at risk EG0026 affected26 at risk EG003
CHILLS	General disorders	27.0	Systematic Assessment	EG00020 affected507 at risk EG0012 affected365 at risk EG0021 affected26 at risk EG003
FATIGUE	General disorders	27.0	Systematic Assessment	EG000116 affected507 at risk EG00167 affected365 at risk EG0026 affected26 at risk EG003
INFLUENZA LIKE ILLNESS	General disorders	27.0	Systematic Assessment	EG00018 affected507 at risk EG0015 affected365 at risk EG0020 affected26 at risk EG003
MALAISE	General disorders	27.0	Systematic Assessment	EG00011 affected507 at risk EG0018 affected365 at risk EG0020 affected26 at risk EG003
MUCOSAL INFLAMMATION	General disorders	27.0	Systematic Assessment	EG00015 affected507 at risk EG00119 affected365 at risk EG0020 affected26 at risk EG003
OEDEMA PERIPHERAL	General disorders	27.0	Systematic Assessment	EG00068 affected507 at risk EG00131 affected365 at risk EG0024 affected26 at risk EG003
PAIN	General disorders	27.0	Systematic Assessment	EG0009 affected507 at risk EG0019 affected365 at risk EG0022 affected26 at risk EG003
PYREXIA	General disorders	27.0	Systematic Assessment	EG00090 affected507 at risk EG00143 affected365 at risk EG0024 affected26 at risk EG003
BRONCHITIS	Infections and infestations	27.0	Systematic Assessment	EG00083 affected507 at risk EG00179 affected365 at risk EG0025 affected26 at risk EG003
CONJUNCTIVITIS	Infections and infestations	27.0	Systematic Assessment	EG00015 affected507 at risk EG00123 affected365 at risk EG0022 affected26 at risk EG003
FUNGAL INFECTION	Infections and infestations	27.0	Systematic Assessment	EG0005 affected507 at risk EG0013 affected365 at risk EG0022 affected26 at risk EG003
GASTROENTERITIS	Infections and infestations	27.0	Systematic Assessment	EG00024 affected507 at risk EG00110 affected365 at risk EG0022 affected26 at risk EG003
HERPES ZOSTER	Infections and infestations	27.0	Systematic Assessment	EG0008 affected507 at risk EG00114 affected365 at risk EG0020 affected26 at risk EG003
INFLUENZA	Infections and infestations	27.0	Systematic Assessment	EG00023 affected507 at risk EG00117 affected365 at risk EG0022 affected26 at risk EG003
NASOPHARYNGITIS	Infections and infestations	27.0	Systematic Assessment	EG00087 affected507 at risk EG00142 affected365 at risk EG0022 affected26 at risk EG003
PHARYNGITIS	Infections and infestations	27.0	Systematic Assessment	EG00019 affected507 at risk EG00117 affected365 at risk EG0022 affected26 at risk EG003
RHINITIS	Infections and infestations	27.0	Systematic Assessment	EG00056 affected507 at risk EG00134 affected365 at risk EG0020 affected26 at risk EG003
SINUSITIS	Infections and infestations	27.0	Systematic Assessment	EG00042 affected507 at risk EG00120 affected365 at risk EG0022 affected26 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	27.0	Systematic Assessment	EG00048 affected507 at risk EG00122 affected365 at risk EG0025 affected26 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	27.0	Systematic Assessment	EG00044 affected507 at risk EG00127 affected365 at risk EG0020 affected26 at risk EG003
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG00058 affected507 at risk EG00125 affected365 at risk EG0021 affected26 at risk EG003
LYMPHOCYTE COUNT DECREASED	Investigations	27.0	Systematic Assessment	EG0004 affected507 at risk EG0016 affected365 at risk EG0022 affected26 at risk EG003
WEIGHT DECREASED	Investigations	27.0	Systematic Assessment	EG00019 affected507 at risk EG00113 affected365 at risk EG0022 affected26 at risk EG003
WEIGHT INCREASED	Investigations	27.0	Systematic Assessment	EG0008 affected507 at risk EG0017 affected365 at risk EG0022 affected26 at risk EG003
WHITE BLOOD CELL COUNT DECREASED	Investigations	27.0	Systematic Assessment	EG00014 affected507 at risk EG00144 affected365 at risk EG0020 affected26 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG00019 affected507 at risk EG00114 affected365 at risk EG0021 affected26 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00079 affected507 at risk EG00152 affected365 at risk EG0024 affected26 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00075 affected507 at risk EG00149 affected365 at risk EG0025 affected26 at risk EG003
BONE PAIN	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00022 affected507 at risk EG00137 affected365 at risk EG0021 affected26 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00070 affected507 at risk EG00116 affected365 at risk EG0022 affected26 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00073 affected507 at risk EG00116 affected365 at risk EG0022 affected26 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00039 affected507 at risk EG00115 affected365 at risk EG0022 affected26 at risk EG003
DIZZINESS	Nervous system disorders	27.0	Systematic Assessment	EG00045 affected507 at risk EG00117 affected365 at risk EG0020 affected26 at risk EG003
DYSGEUSIA	Nervous system disorders	27.0	Systematic Assessment	EG00023 affected507 at risk EG00124 affected365 at risk EG0020 affected26 at risk EG003
HEADACHE	Nervous system disorders	27.0	Systematic Assessment	EG00066 affected507 at risk EG00131 affected365 at risk EG0023 affected26 at risk EG003
HYPOAESTHESIA	Nervous system disorders	27.0	Systematic Assessment	EG0008 affected507 at risk EG0018 affected365 at risk EG0020 affected26 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	27.0	Systematic Assessment	EG00035 affected507 at risk EG00172 affected365 at risk EG0022 affected26 at risk EG003
PARAESTHESIA	Nervous system disorders	27.0	Systematic Assessment	EG00037 affected507 at risk EG00146 affected365 at risk EG0023 affected26 at risk EG003
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	27.0	Systematic Assessment	EG00018 affected507 at risk EG00121 affected365 at risk EG0023 affected26 at risk EG003
ANXIETY	Psychiatric disorders	27.0	Systematic Assessment	EG00027 affected507 at risk EG00124 affected365 at risk EG0020 affected26 at risk EG003
DEPRESSION	Psychiatric disorders	27.0	Systematic Assessment	EG00020 affected507 at risk EG00121 affected365 at risk EG0022 affected26 at risk EG003
INSOMNIA	Psychiatric disorders	27.0	Systematic Assessment	EG00031 affected507 at risk EG00134 affected365 at risk EG0023 affected26 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG000104 affected507 at risk EG00144 affected365 at risk EG0024 affected26 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG00055 affected507 at risk EG00133 affected365 at risk EG0025 affected26 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0004 affected507 at risk EG0013 affected365 at risk EG0022 affected26 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG00025 affected507 at risk EG00114 affected365 at risk EG0021 affected26 at risk EG003
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG00012 affected507 at risk EG0013 affected365 at risk EG0022 affected26 at risk EG003
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG00012 affected507 at risk EG0015 affected365 at risk EG0020 affected26 at risk EG003
ALOPECIA	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0005 affected507 at risk EG00139 affected365 at risk EG0022 affected26 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00044 affected507 at risk EG00113 affected365 at risk EG0020 affected26 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00038 affected507 at risk EG0019 affected365 at risk EG0022 affected26 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00018 affected507 at risk EG0014 affected365 at risk EG0022 affected26 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00086 affected507 at risk EG00122 affected365 at risk EG0023 affected26 at risk EG003
RASH	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG000141 affected507 at risk EG00122 affected365 at risk EG0021 affected26 at risk EG003
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG00019 affected507 at risk EG0015 affected365 at risk EG0021 affected26 at risk EG003
HOT FLUSH	Vascular disorders	27.0	Systematic Assessment	EG00016 affected507 at risk EG0015 affected365 at risk EG0020 affected26 at risk EG003
HYPERTENSION	Vascular disorders	27.0	Systematic Assessment	EG00023 affected507 at risk EG00113 affected365 at risk EG0022 affected26 at risk EG003
HYPOTENSION	Vascular disorders	27.0	Systematic Assessment	EG00016 affected507 at risk EG0015 affected365 at risk EG0022 affected26 at risk EG003
PHLEBITIS	Vascular disorders	27.0	Systematic Assessment	EG0002 affected507 at risk EG0014 affected365 at risk EG0020 affected26 at risk EG003

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
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

ID	Title	Description
BG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.
BG001	Investigator Choice	Rituximab-CHOP: with six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m^2 rituximab and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-CVP: with eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles, OR Rituximab-Bendamustine: with rituximab 375 mg/m^2 (day 1) plus bendamustine 90 mg/m^2 (days 1 + 2) every 28 days for six cycles; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rituximab-Lenalidomide	Rituximab, 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles. Six cycles of lenalidomide 20 mg daily on days 2-22 every 28 days.	88	513	181	507	496	507
EG001	Investigator Choice Rituximab-CHOP	Six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m^2 rituximab and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.	71	372	109	365	351	365
EG002	Investigator Choice Rituximab-CVP	Eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.	7	28	7	26	26	26
EG003	Investigator Choice Rituximab-Bendamustine	Rituximab 375 mg/m^2 (day 1) plus bendamustine 90 mg/m^2 (days 1 + 2) every 28 days for six cycles; and 8 weeks later responding patients continue with 375 mg/m^2 rituximab every 8 weeks for 12 cycles.	12	117	32	112	108	112