Fludarabine and Cyclophosphamide With or Without Rituxima... | NCT00281918

Status Module

Name	Class
German CLL Study Group	OTHER

Label	Type	Description	Intervention Names
Fludarabine+Cyclophosphamide+Rituximab (FCR)	Experimental		Drug: Rituximab Drug: Cyclophosphamide Drug: Fludarabine Phosphate
Fludarabine+Cyclophosphamide (FC)	Active Comparator		Drug: Cyclophosphamide Drug: Fludarabine Phosphate

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug	Intravenous repeating dose	Fludarabine+Cyclophosphamide+Rituximab (FCR)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS)	Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.	Median observation time at time of analysis was approximately 21 months
Final Analysis: Time to Progression-free Survival Event	Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.	Median observation time was approximately 66.4 months

Secondary Outcomes

Measure	Description	Time Frame
Event-free Survival (EFS)	Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.	Median observation time at time of analysis was approximately 21 months
Overall Survival (OS)

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria
Meets 1 of the following criteria:
- Binet stage C disease
- Binet stage B disease AND ≥ 1 of the following signs or symptoms*:
  - B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers > 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue)
  - Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count > 50 G/I)
  - Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia
  - Massive, progressive or painful splenomegaly or hypersplenism
  - Massive lymph nodes or lymph node clusters (> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy
  - Occurrence of symptomatic hyperviscosity problems at leukocyte counts > 200 G/I (symptomatic leukostasis) NOTE: * Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility
No Binet stage A disease
No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia)

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Cumulative Illness Rating Scale (CIRS) score > 6
Life expectancy > 6 months
Bilirubin ≤ 2 times upper limit of normal (ULN)
Alkaline phosphatase and transaminases ≤ 2 times ULN
Creatinine clearance ≥ 70 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 2 months after study treatment
No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
No cerebral dysfunction that precludes chemotherapy
No active bacterial, viral, or fungal infection
No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia
No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery
No medical or psychological condition that would preclude study therapy
No concurrent disease that requires prolonged (> 1 month) therapy involving glucocorticoids

PRIOR CONCURRENT THERAPY:

No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy

Name	Affiliation	Role
Michael Hallek, MD	Medizinische Universitaetsklinik I at the University of Cologne	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Gosford Hospital		Gosford	New South Wales	2250	Australia
Westmead Institute for Cancer Research at Westmead Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38620092	Derived	Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.
33730841

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
FG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
BG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-free Survival (PFS)

Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.

The Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.

Posted

Median

Full Range

Days

Median observation time at time of analysis was approximately 21 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Units	Counts
Participants	OG000407 OG001403

Title

Denominators

Categories

Title	Measurements
	OG000981.0(1 to 1343) OG0011212.0(1 to 1372)

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		<.0001							95						No	Superiority or Other

Secondary

Event-free Survival (EFS)

Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.

The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.

Posted

Median

Full Range

Days

Median observation time at time of analysis was approximately 21 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Secondary

Overall Survival (OS)

Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.

Posted

Number

Days

Median observation time at time of analysis was approximately 21 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Secondary

Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).

CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.

Posted

Number

Days to an event

Median observation time at time of analysis was approximately 21 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Primary

Final Analysis: Time to Progression-free Survival Event

Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.

Participants from the Intent-to-treat population, that included all randomized participants, with PFS events.

Posted

Median

95% Confidence Interval

Days

Median observation time was approximately 66.4 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Units	Counts

Secondary

Final Analysis: Time to Overall Survival Event

Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.

Participants from the Intent-to-treat population, that included all randomized participants who died.

Posted

Median

95% Confidence Interval

Days

Median observation time was approximately 66.4 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Units	Counts
Participants

Secondary

Final Analysis: Time to Event-free Survival Event

Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.

Participants from the Intent-to-treat population, that included all randomized participants, with disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death.

Posted

Median

95% Confidence Interval

Days

Median observation time was approximately 66.4 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Secondary

Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)

Participants from the Intent-to-treat population, all randomized participants, with complete response who experienced a disease free survival event (disease relapse or death).

Posted

Median

95% Confidence Interval

Days

Median observation time was approximately 66.4 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Secondary

Final Analysis: Duration of Response

Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.

Participants from the Intent-to-treat population, all randomized participants, with complete response or partial response who experienced an event (disease progression or death due to any cause).

Posted

Median

95% Confidence Interval

Days

Median observation time was approximately 66.4 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Units

Secondary

Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response

CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.

Intent-to-treat population included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Median observation time was approximately 66.4 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Secondary

Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)

The time from randomization to the start of a new treatment.

Participants from the Intent-to-treat population, that included all randomized participants, who started a new CLL treatment.

Posted

Median

95% Confidence Interval

Days

Median observation time was approximately 66.4 months

ID	Title	Description
OG000	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
OG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.

Units	Counts
Participants

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	Fludarabine+Cyclophosphamide (FC)	Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.			164	398	122	398
EG001	Fludarabine+Cyclophosphamide+Rituximab (FCR)	Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.			186	402	185	402

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00021 affected398 at risk EG00118 affected402 at risk
Herpes Zoster	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0006 affected398 at risk EG0018 affected402 at risk
Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0008 affected398 at risk EG0015 affected402 at risk
Bronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0005 affected398 at risk EG0015 affected402 at risk
Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0015 affected402 at risk
Gastroenteritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 affected398 at risk EG0012 affected402 at risk
Sinusitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0014 affected402 at risk
Erysipelas	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0012 affected402 at risk
Hepatitis B	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0011 affected402 at risk
Pneumocystis Jiroveci Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0012 affected402 at risk
Pneumocystis Jiroveci Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0012 affected402 at risk
Pneumonia Primary Atypical	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0012 affected402 at risk
Viral Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0013 affected402 at risk
Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Cerebral Toxoplasmosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Diverticulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Neutropenic Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Oral Herpes	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0010 affected402 at risk
Pneumonia Fungal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Appendicitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Bronchiolitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Bronchopneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Chronic Sinusitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Cytomegalovirus Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Enterococcal Bacteraemia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Gastroenteritis Cryptosporidial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Hepatitis C	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Hepatobiliary Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Herpes Simplex	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Herpes Virus Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Herpes Zoster Ophthalmic	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Lung Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Lung Infection Pseudomonal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Neutropenic Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Oesophageal Candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Orchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Osteomyelitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Otitis Media	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Periorbital Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Pneumonia Respiratory Syncytial Viral	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Pseudomonal Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Septic Shock	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Skin Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Staphylococcal Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Tonsillitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Tuberculosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Urosepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00022 affected398 at risk EG00131 affected402 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00010 affected398 at risk EG0016 affected402 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected398 at risk EG0019 affected402 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected398 at risk EG0018 affected402 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected398 at risk EG0016 affected402 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected398 at risk EG0017 affected402 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected398 at risk EG0011 affected402 at risk
Febrile Bone Marrow Aplasia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0013 affected402 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Haemolytic Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Bone Marrow Failure	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Coombs Positive Haemolytic Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Evans Syndrome	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Haematotoxicity	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG00020 affected398 at risk EG00118 affected402 at risk
Chest Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0013 affected402 at risk
Chills	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Adverse Drug Reaction	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Chest Discomfort	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Death	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
General Physical Health Deterioration	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
General Symptom	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Ill-Defined Disorder	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Mucosal Inflammation	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Multi-Organ Failure	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0011 affected402 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0011 affected402 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0012 affected402 at risk
Tumour Lysis Syndrome	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0011 affected402 at risk
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Lung Squamous Cell Carcinoma Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0010 affected402 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Central Nervous System Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Histiocytosis Haematophagic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Hodgkin's Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Lymphoma Transformation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Non-Small Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Pharyngeal Cancer Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Skin Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Squamous Cell Carcinoma of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0012 affected402 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0011 affected402 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0011 affected402 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Alveolitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Dyspnoea at Rest	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Laryngeal Stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Respiration Abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Angina Pectoris	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0015 affected402 at risk
Cardiac Failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0010 affected402 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0010 affected402 at risk
Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Arrhythmia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Supraventricular Extrasystoles	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0015 affected402 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0013 affected402 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected398 at risk EG0011 affected402 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Abdominal Symptom	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Constipation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Duodenal Ulcer Perforation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Gastrointestinal Ulcer	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Inguinal Hernia, Obstructive	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Tongue Ulceration	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Syncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0012 affected402 at risk
Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0012 affected402 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Convulsion	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Diabetic Neuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Encephalitis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Epilepsy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Hemiparesis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Hydrocephalus	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Migraine	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Optic Neuritis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Stupor	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Cerebral Infarction	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Dermatitis Exfoliative	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Leukocytoclastic Vasculitis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0010 affected402 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0010 affected402 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Pustular Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0011 affected402 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Hepatic Siderosis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Hypersensitivity	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0013 affected402 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Cytokine Release Syndrome	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Retinal Detachment	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Amaurosis Fugax	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Dacryostenosis Acquired	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Uveitis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Vitreous Haemorrhage	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Catheterisation Cardiac	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Coronary Revascularisation	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Haemorrhoid Operation	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Prostatectomy	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Surgery	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Post Procedural Complication	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Body Temperature Increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Completed Suicide	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0012 affected402 at risk
Cystitis Haemorrhagic	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0012 affected402 at risk
Renal Failure	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0012 affected402 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected398 at risk EG0010 affected402 at risk
Circulatory Collapse	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Vasculitis Necrotising	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Venous Thrombosis Limb	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Device related infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk
Infectious pleural effusion	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Device occlusion	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected398 at risk EG0011 affected402 at risk
Gout	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0010 affected402 at risk
Endophthalmitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected398 at risk EG0011 affected402 at risk

ID	Type	Description	Link
GCLLSG-CLL-8
EU-20560
ML17102

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds

ID	Term
D007938	Leukemia
D015451	Leukemia, Lymphocytic, Chronic, B-Cell

ID	Term
D000069283	Rituximab
D003520	Cyclophosphamide
C042382	fludarabine phosphate