A Study of MabThera (Rituximab) in Elderly Patients With... | NCT01144364

Label	Type	Description	Intervention Names
1	Experimental		Drug: rituximab [Mabthera/Rituxan]

Name	Type	Description	Arm Group Labels	Other Names
rituximab [Mabthera/Rituxan]	Drug	Intravenous repeating dose	1

Measure	Description	Time Frame
Percentage of Participants With Disease Progression or Death	PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.	12, 24, and 34 months
PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months	PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.	12, 24, and 34 months

Measure	Description	Time Frame
Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months	PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia		Pescara	Abruzzo	65100	Italy
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

PubMed Identifier	Type	Citation	Retractions
24085766	Derived	Ladetto M, Lobetti-Bodoni C, Mantoan B, Ceccarelli M, Boccomini C, Genuardi E, Chiappella A, Baldini L, Rossi G, Pulsoni A, Di Raimondo F, Rigacci L, Pinto A, Galimberti S, Bari A, Rota-Scalabrini D, Ferrari A, Zaja F, Gallamini A, Specchia G, Musto P, Rossi FG, Gamba E, Evangelista A, Vitolo U; Fondazione Italiana Linfomi. Persistence of minimal residual disease in bone marrow predicts outcome in follicular lymphomas treated with a rituximab-intensive program. Blood. 2013 Nov 28;122(23):3759-66. doi: 10.1182/blood-2013-06-507319. Epub 2013 Oct 1.
23960180

ID	Title	Description
FG000	Induction Phase-Immunochemotherapy Rituximab-FND (R-FND)	Cycles 1 to 4: Participants received rituximab: 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1, fludarabine (F): 25 mg/m^2 IV on Days 2-4, mitoxantrone (N): 10 mg/m^2 IV on Day 2, dexamethasone (D) 10 mg IV (total dose) on Days 2-4. Cycles were repeated every 28 days for a total of 4 cycles. *In Cycle 1, rituximab was given on Day 8 in order to avoid tumour lysis syndrome. Consequently, in Cycle 1, fludarabine and dexamethasone were given on Days 1, 2, and 3. Mitoxantrone was given on Day 1.

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

Percentage of Participants With Disease Progression or Death

PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.

ITT population

Posted

Number

percentage of participants

12, 24, and 34 months

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
OG001	Rituximab Induction, Observation Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.

Units	Counts
Participants	OG000101 OG001101

Title

Denominators

Categories

Title	Measurements
	OG00029.7 OG00134.7

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	Difference between treatment arms	Log Rank		0.254														Superiority or Other

Secondary

Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months

PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.

IP population

Posted

Number

95% Confidence Interval

percentage of participants

12, 24, and 36 months

ID	Title	Description
OG000	Rituximab Induction	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no therapy (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.

Secondary

Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months

DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.

ITT population

Posted

Number

95% Confidence Interval

percentage of participants

12, 24, and 36 months

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.

Secondary

Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months

OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.

ITT population.

Posted

Number

95% Confidence Interval

percentage of participants

12, 24, and 34 months

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
OG001	Rituximab Induction, Observation Maintenance

Secondary

Overall Survival (OS) From Randomization - Percentage of Participants With Death

ITT population.

Posted

Number

percentage of participants

12, 24, and 34 months

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
OG001	Rituximab Induction, Observation Maintenance

Secondary

OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months

OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.

IP population

Posted

Number

95% Confidence Interval

percentage of participants

12, 24, and 36 months

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.

Primary

PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months

PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.

ITT population

Posted

Number

95% Confidence Interval

percentage of participants

12, 24, and 34 months

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
OG001	Rituximab Induction, Observation Maintenance

Secondary

Percentage of Participants With a Response During the Induction Phase

Participants without a response assessment (due to any reasons) were considered as non-responders.

ITT population.

Posted

Number

percentage of participants

Months 1 to 8

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
OG001	Rituximab Induction, Observation Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.

Secondary

Percentage of Participants With a Molecular Response in the Induction Phase

Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment.

IP population; only participants with a positive bcl-2/IgH (NHL marker) at baseline were included in the analysis.

Posted

Number

percentage of participants

Months 5 and 8

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no treatment (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.

Secondary

Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months

Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.

ITT Population

Posted

Number

95% Confidence Interval

percentage of participants

Months 12, 24, and 34

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.

Secondary

Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months

DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.

ITT Population

Posted

Number

95% Confidence Interval

percentage of participants

Months 12, 24, and 34

ID	Title	Description
OG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypersensitivity	Immune system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Pyrexia	Immune system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Atrial fibrillation	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Intestinal obstruction	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Intestinal perforation	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Cytomegalovirus infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Febrile neutropenia	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hepatitis B	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0022 affected101 at risk
Pneumonitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Sepsis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Spinal compression fracture	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Chest pain	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Deep vein thrombosis	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Pulmonary embolism	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Neutropenia	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Cardiac ablation	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Wolff-Parkinson-White syndrome	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Cardiomyopathy	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Myocardial infarction	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Diabetic vascular disorder	Endocrine disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Cholecystitis acute	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Diarrhoea	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Haemorrhoids	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Herpes zoster	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Pneumonia	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0022 affected101 at risk
Septic shock	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Transient ischaemic shock	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Renal cyst	Renal and urinary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Sarcoidosis	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Angina pectoris	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0022 affected101 at risk
Aortic valve stenosis	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Cardiac failure	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Thrombosis	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
General physical health deterioration	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Cholelithiasis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0023 affected101 at risk
Femur fracture	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Hip arthroplasty	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Upper limb fracture	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Cerebrovascular accident	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Cataract operation	Eye disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Ovarian adenoma	Reproductive system and breast disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Plasmablastic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchospasm	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Bronchopneumonia	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Cytomegalovirus infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Ear infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Escherichia infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Fungal infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Genitourinary tract infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Herpes simplex	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0006 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Herpes zoster	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0004 affected233 at risk EG0012 affected101 at risk EG0023 affected101 at risk
Klebsiella infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Klebsiella sepsis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Onychomycosis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Pneumonia	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Prostate infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Pseudomonas infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Respiratory tract infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Tonsillitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Tooth abscess	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Urinary tract infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Vaginal candidiasis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Viral infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Viral DNA test positive	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Hepatitis B	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Pneumonitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Upper respiratory tract infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Bronchitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0011 affected101 at risk EG0027 affected101 at risk
Lung infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Nasopharyngeal disorder	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Pharyngitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0022 affected101 at risk
Rhinitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0014 affected101 at risk EG0022 affected101 at risk
Influenza	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0007 affected233 at risk EG0015 affected101 at risk EG0029 affected101 at risk
Diverticulitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Gastroenteritis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Laryngitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Choking sensation	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Drug hypersensitivity	Immune system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0006 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Hypersensitivity	Immune system disorders	CTCAE (3.0)	Non-systematic Assessment	EG00011 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Edema	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG00011 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hyperpyrexia	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hyperthermia	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Infusion related reaction	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Oedema	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0022 affected101 at risk
Oedema peripheral	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0007 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Pharyngeal oedema	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0018 affected101 at risk EG0020 affected101 at risk
Pyrexia	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG00044 affected233 at risk EG0018 affected101 at risk EG0023 affected101 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Alopecia	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG00015 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Dermatitis	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Erythema	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Pruritus	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0004 affected233 at risk EG0010 affected101 at risk EG0023 affected101 at risk
Rash	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Skin	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0008 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Skin lesion	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Urticaria	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Eczema	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Neck mass	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Psoriasis	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Skin infection	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Altered hearing	Ear and labyrinth disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Deafness	Ear and labyrinth disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Anaemia	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG000103 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Neutropenia	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG000225 affected233 at risk EG00116 affected101 at risk EG0022 affected101 at risk
Thrombocytopenia	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG000120 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Leukopenia	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0015 affected101 at risk EG0020 affected101 at risk
Lymphopenia	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Atrial flutter	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Palpitations	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Bradycardia	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Extrasystoles	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Arrhythmia	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Ischaemia	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Sinus tachycardia	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Ventricular extrasystoles	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Syncope	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Hypertension	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0007 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Hypotension	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Pulse pressure increased	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Asthenia	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG00016 affected233 at risk EG0014 affected101 at risk EG0025 affected101 at risk
Asthenia/fatigue	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG00057 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Chills	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0004 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Fatigue	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Oedema mucosal	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Hypothermia	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Mucosal inflammation	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0006 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Feeling hot	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Diabetes mellitus	Endocrine disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Diabetic vascular disorder	Endocrine disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Goitre	Endocrine disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hyperglycaemia	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Anorexia	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG00016 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Insomnia	Psychiatric disorders	CTCAE (3.0)	Non-systematic Assessment	EG0007 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Weight increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Aphonia	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Weight decreased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Hypothyroidism	Endocrine disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Hyperthyroidism	Endocrine disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Thyroiditis chronic	Endocrine disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Abdominal ridigity	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Anal ulcer	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Colitis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Constipation	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG00024 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Diarrhoea	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG00023 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Dyspepsia	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Gastric ulcer	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Gastritis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0005 affected233 at risk EG0010 affected101 at risk EG0023 affected101 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Gingivitis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Haemorrhoids	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Nausea	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG00043 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Oesophagitis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Pulpitis dental	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Stomatitis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG00023 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Vomiting	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0008 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Furuncle	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Febrile neutropenia	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Anal discomfort	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Anal haemorrhage	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Diverticulum	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Duodenal ulcer	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Enteritis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Flatulence	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Gastrointestinal infection	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Haematochezia	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Helicobacter gastritis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Helicobacter pylori identification test positive	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Hepatitis viral	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Pancreatic disorder	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Polyp colorectal	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Reflux oesophagitis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Aphthous stomatitis	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0022 affected101 at risk
Abdominal pain	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG00010 affected233 at risk EG0012 affected101 at risk EG0022 affected101 at risk
Abdominal pain upper	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG00012 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Blood amylase increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Cholelithiasis	Hepatobiliary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Liver function test abnormal	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Alanine aminotransferase increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Aspartate aminotransferase increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Beta 2 microglobulin increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Blood immunoglobulin A decreased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Blood immunoglobulin G decreased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Blood immunoglobulin M decreased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Blood lactate dehydrogenase increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0004 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Blood uric acid increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Gamma-glutamyltransferase increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Hyperuricaemia	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG0004 affected233 at risk EG0012 affected101 at risk EG0022 affected101 at risk
Blood alkaline phosphatase increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Blood bilirubin increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Blood creatinine increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Blood glucose increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Gamma-glutamyltransferase	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Hyperkalaemia	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hypokalaemia	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Red blood cell sedimentation rate increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Transaminases abnormal	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Transaminases increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Blood alkaline phosphatase	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Blood amylase	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Alanine aminotransferase	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Blood potassium increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Haemoglobin increaed	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Fistula	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hepatomegaly	Hepatobiliary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hiatus hernia	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Iron deficiency	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Ejection fracture decreased	Cardiac disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Ascites	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Aptyalism	Endocrine disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Total bile acids increased	Investigations	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Neutrophilia	Blood and lymphatic system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hypernatraemia	Metabolism and nutrition disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Clavicle fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0025 affected101 at risk
Spinal fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Back pain	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG00010 affected233 at risk EG0010 affected101 at risk EG0024 affected101 at risk
Bone pain	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0007 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Chest pain	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0004 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Ear pain	Ear and labyrinth disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Myalgia	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0009 affected233 at risk EG0012 affected101 at risk EG0021 affected101 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0005 affected233 at risk EG0014 affected101 at risk EG0021 affected101 at risk
Pelvic pain	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0003 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Pain	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG00031 affected233 at risk EG0010 affected101 at risk EG00213 affected101 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG00017 affected233 at risk EG0011 affected101 at risk EG0022 affected101 at risk
Ankle fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Foot fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Bone density increased	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Humerus fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Neck pain	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0021 affected101 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Groin pain	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Movement disorder	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Upper limb fracture	Injury, poisoning and procedural complications	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Conjunctivitis	Eye disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0023 affected101 at risk
Dysuria	Renal and urinary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0004 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Cough	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG00017 affected233 at risk EG00113 affected101 at risk EG00210 affected101 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0007 affected233 at risk EG0011 affected101 at risk EG0025 affected101 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0022 affected101 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Anxiety	Psychiatric disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Confusional state	Psychiatric disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Depressed mood	Psychiatric disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Depression	Psychiatric disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Dizziness	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0013 affected101 at risk EG0020 affected101 at risk
Facial palsy	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Irritability	General disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Neuropathy	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Neuropathy: motor	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0005 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Neuropathy: sensory	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0009 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Paraesthesia	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Paraesthesia oral	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Peripheral sensory neuropathy	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Vertigo	Ear and labyrinth disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Cataract	Eye disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Glaucoma	Eye disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Headache	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0007 affected233 at risk EG0013 affected101 at risk EG0020 affected101 at risk
Migraine	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Amnesia	Psychiatric disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Epilepsy	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Diplopia	Eye disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Visual acuity reduced	Eye disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0012 affected101 at risk EG0020 affected101 at risk
Toothache	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Vagotomy	Nervous system disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Exostosis	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Vitreous haemorrhage	Eye disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Inguinal hernia	Gastrointestinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Osteitis deformans	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0005 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Deep vein thrombosis	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0004 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Phlebitis	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Hypertensive crisis	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Blood pressure increased	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Carotid artery stenosis	Vascular disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0022 affected101 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Benign prostatic hyperplasia	Renal and urinary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Cystitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0005 affected233 at risk EG0011 affected101 at risk EG0024 affected101 at risk
Incontinence	Renal and urinary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Micturition urgency	Renal and urinary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0020 affected101 at risk
Pollakiuria	Renal and urinary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Urinary tract disorder	Renal and urinary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Prostate examination abnormal	Renal and urinary disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0010 affected101 at risk EG0021 affected101 at risk
Vaginal burning sensation	Reproductive system and breast disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Bronchitis chronic	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Nasopharyngitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Sinusitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Tracheitis	Infections and infestations	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected101 at risk EG0020 affected101 at risk

ID	Term
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

ID	Title	Description
BG000	Rituximab Induction, Rituximab Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.
BG001	Rituximab Induction, Observation Maintenance	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rituximab Induction (Induction Phase Only)	Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).	19	233	230	233
EG001	Rituximab Induction, Rituximab Maintenance (Follow-up Phase)	Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses.	19	101	73	101
EG002	Rituximab Induction, Observation Maintenance (Follow-up Phase)	Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8. Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4. One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses). Maintenance Phase: no further therapy, observation only.	17	101	55	101