A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumuma... | NCT01578707

ID	Type	Description	Link
2012-000694-23	EudraCT Number

Name	Class
Janssen Research & Development, LLC	INDUSTRY

Label	Type	Description	Intervention Names
Ofatumumab (Arm A)	Active Comparator	An anti-CD20 monoclonal antibody	Drug: ofatumumab
ibrutinib (Arm B)	Experimental	A Bruton Tyrosine Kinase Inhibitor	Drug: ibrutinib

Name	Type	Description	Arm Group Labels	Other Names
ofatumumab	Drug	The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)

Measure	Description	Time Frame
PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013	The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.	Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.

Measure	Description	Time Frame
Overall Response Rate (ORR) by Independent Review Committee (IRC)	Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013	About 18 months after the first subject was enrolled
OS (Overall Survival)

Measure	Description	Time Frame
Progression Free Survival (PFS) by Investigator With up to 6 Years of Study Follow-up	Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up	From study initiation to study closure, including up to 6 years of study follow-up
Overall Response Rate (ORR) by Investigator

Name	Affiliation	Role
Anita Szoke, MD	Pharmacyclics LLC.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site #408		La Jolla	California	92093-0698	United States
Site #377

PubMed Identifier	Type	Citation	Retractions
40266025	Derived	Abuhelwa AY, Almansour SA, Brown JR, Al-Shamsi HO, Abuhelwa Z, Kharaba Z, Bustanji Y, Semreen MH, Ali S, Alhuraiji A, McKinnon RA, Sorich MJ, Alzoubi KH, Hopkins AM. Statin use and survival in CLL/SLL treated with ibrutinib: pooled analysis of 4 randomized controlled trials. Blood Adv. 2025 Jul 22;9(14):3566-3575. doi: 10.1182/bloodadvances.2024015287.
31512258

ID	Title	Description
FG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 28, 2016	Jul 9, 2019

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

PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013

The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.

Posted

Median

95% Confidence Interval

months

Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.

ID	Title	Description
OG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
OG001	Ibrutinib (Arm B)	A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Units	Counts
Participants	OG000196 OG001195

Title

Denominators

Categories

Title	Measurements
	OG0008.1(7.2 to 8.3) OG001NA(NA to NA)IBR: Median PFS was not reached so 95% CI for median PFS is not applicable.

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		Log Rank		<0.0001														Superiority

Secondary

Overall Response Rate (ORR) by Independent Review Committee (IRC)

Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013

Posted

Number

percentage of participants

About 18 months after the first subject was enrolled

ID	Title	Description
OG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
OG001	Ibrutinib (Arm B)	A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Units	Counts
Participants	OG000

Secondary

OS (Overall Survival)

OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm

Posted

Median

95% Confidence Interval

months

OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up

ID	Title	Description
OG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
OG001	Ibrutinib (Arm B)	A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Units	Counts
Participants	OG000

Secondary

Rate of Sustained Hemoglobin and Platelet Improvement

Proportion of subjects with hemoglobin (HgB) increase >=20 g/L and platelet (PLT) increase >=50% over baseline continuously for >=56 days without blood transfusions or growth factors.

Posted

Number

percentage of participants

From study initiation to study closure, including up to 6 years of study follow-up

ID	Title	Description
OG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
OG001	Ibrutinib (Arm B)	A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Units	Counts
Participants	OG000

Other Pre-specified

Progression Free Survival (PFS) by Investigator With up to 6 Years of Study Follow-up

Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up

Posted

Median

95% Confidence Interval

months

From study initiation to study closure, including up to 6 years of study follow-up

ID	Title	Description
OG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
OG001	Ibrutinib (Arm B)	A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Units	Counts
Participants	OG000

Other Pre-specified

Overall Response Rate (ORR) by Investigator

Overall response per the IWCLL 2008 criteria as assessed by Investigator with up to 6 years of study follow-up

Posted

Number

percentage of participants

From study initiation to study closure, including up to 6 years of study follow-up

ID	Title	Description
OG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
OG001	Ibrutinib (Arm B)	A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG0017 affected195 at risk
Anaemia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG0015 affected195 at risk
Neutropenia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0014 affected195 at risk
Spontaneous Haematoma	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Autoimmune Haemolytic Anaemia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Haemolytic Anaemia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Methaemoglobinaemia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Atrial Fibrillation	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG00111 affected195 at risk
Cardiac Failure Congestive	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Atrioventricular Block	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Cardiac Failure	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0012 affected195 at risk
Myocardial infarction	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0012 affected195 at risk
Acute myocardial infarction	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Angina Pectoris	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Aortic Valve Disease	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Atrial Tachycardia	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Bradycardia	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Cardiac Arrest	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Myocardial Ischaemia	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Palpitations	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pericardial Effusion	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Supraventricular Tachycardia	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Sinus Tachycardia	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Hypoacusis	Ear and labyrinth disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Vitreous Haemorrhage	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Diarrhoea	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0016 affected195 at risk
Vomiting	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0015 affected195 at risk
Abdominal Pain	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0014 affected195 at risk
Nausea	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Umbilical Hernia	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Anorectal Discomfort	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Duodenal Perforation	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Dysphagia	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Enteritis	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Intestinal Obstruction	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Large Intestinal Obstruction	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Mucous stools	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Oesophageal Obstruction	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Oesophageal spasm	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pancreatitis	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Poor Dental Condition	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Rectal haemorrhage	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Stomatitis	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Constipation	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Malabsorption	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Pyrexia	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG00115 affected195 at risk
Non-Cardiac Chest Pain	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Malaise	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Sudden Death	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Asthenia	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Catheter Site Pain	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Chills	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Cyst	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Fatigue	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
General Physical Health Deterioration	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Influenza Like Illness	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Injection Site Extravasation	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Effusion	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Cholecystitis	Hepatobiliary disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Cholestasis	Hepatobiliary disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Anaphylactic Shock	Immune system disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Pneumonia	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG00012 affected191 at risk EG00142 affected195 at risk
Urinary Tract Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0019 affected195 at risk
Cellulitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0018 affected195 at risk
Sepsis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0018 affected195 at risk
Lung Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0017 affected195 at risk
Escherichia Urinary Tract Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0014 affected195 at risk
Lower Respiratory Tract Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0014 affected195 at risk
Upper Respiratory Tract Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG0014 affected195 at risk
Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0013 affected195 at risk
Aspergillus Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Bronchitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0012 affected195 at risk
Bronchopulmonary Aspergillosis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Gastroenteritis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Gastroenteritis Viral	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Herpes Zoster	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0012 affected195 at risk
Influenza	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0012 affected195 at risk
Neutropenic Sepsis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0012 affected195 at risk
Pneumocystis Jirovecii Ppneumonia	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0012 affected195 at risk
Pneumonia Pseudomonal	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0012 affected195 at risk
Pneumonia Staphylococcal	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Sinusitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Urosepsis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Bacteraemia	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0011 affected195 at risk
Bacterial Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Bacteroides Bacteraemia	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Bronchitis Bacterial	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Campylobacter Gastroenteritis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Clostridium Difficile Colitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Clostridium Difficile Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Empyema	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Enterococcal Iinfection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Enterococcal Sepsis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Enterocolitis Infectious	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Folliculitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Gastrointestinal Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
H1N1 Influenza	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Haemophilus Bacteraemia	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Haemophilus Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Haemophilus Sepsis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Herpes Virus Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Impetigo	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Infective Exacerbation of Bronchiectasis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Intervertebral Discitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Lower Respiratory Tract Infection Bacterial	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Lymph Gland Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Meningitis Pneumococcal	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Mycobacterium Avium Complex Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Osteomyelitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Otitis Externa	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Otitis Media	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Parainfluenzae Virus Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pneumococcal Sepsis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pneumocystis Jirovecii Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pneumonia Bacterial	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Pneumonia Respiratory Syncytial Viral	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pneumonia viral	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pseudomonal Sepsis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pseudomonas Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0011 affected195 at risk
Pyelonephritis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Respiratory Tract Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0011 affected195 at risk
Rhinovirus Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Septic Shock	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Staphylococcal Sepsis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Staphylococcal Skin Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Tonsillitis Fungal	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Tooth Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Urethritis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Urinary Tract Infection Pseudomonal	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Viral Pharyngitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Abscess Limb	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Anal Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Breast Cellulitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Febrile Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Herpes Simplex	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Infectious Pleural Effusion	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Lung Infection Pseudomonal	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Nocardiosis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Ophthalmic Herpes Zoster	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Pneumonia Mycoplasmal	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Sepsis Syndrome	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Stenotrophomonas Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0010 affected195 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0016 affected195 at risk
Femur Fracture	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0014 affected195 at risk
Fall	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Hip Fracture	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Brain Contusion	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Burns Third Degree	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Laceration	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Multiple Fractures	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Rib Fracture	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Subarachnoid Haematoma	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Subarachnoid Haemorrhage	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Subdural Haemorrhage	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Traumatic Haematoma	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0010 affected195 at risk
Muscle Strain	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Immunoglobulins Decreased	Investigations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Hyponatraemia	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Dehydration	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Hypokalaemia	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Iron Deficiency	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Tumour Lysis Syndrome	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0014 affected195 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Chronic Lymphocytic Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG0015 affected195 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Richter's Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Hodgkin's Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Bone Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Brain Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Colon Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Desmoid Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Gastrointestinal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Histiocytic Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Intraductal Papillary Mucinous Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Myelodysplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Squamous Cell Carcinoma of Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Tumour Flare	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Metastatic Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Tumour Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Seizure	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Cerebrovascular Accident	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Transient Ischaemic Attack	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Cerebral Haemorrhage	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Dizziness	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Encephalopathy	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Sciatica	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Syncope	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Mental Status Changes	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Depression	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Hallucination, Visual	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Mania	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Psychotic Disorder	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Confusional State	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Major Depression	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Acute Kidney Injury	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG0014 affected195 at risk
Haematuria	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Urinary Retention	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Calculus Bladder	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Hydronephrosis	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Ureterolithiasis	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Renal Failure	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Renal Impairment	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0014 affected195 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0013 affected195 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0013 affected195 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0011 affected195 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Respiratory Tract Inflammation	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk
Angioedema	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Pyoderma Gangrenosum	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Hypertension	Vascular disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0012 affected195 at risk
Aneurysm	Vascular disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG0011 affected195 at risk
Deep Vein Thrombosis	Vascular disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG0010 affected195 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG00032 affected191 at risk EG00162 affected195 at risk
Neutropenia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG00025 affected191 at risk EG00160 affected195 at risk
Increased Tendency to Bruise	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG00145 affected195 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG00022 affected191 at risk EG00145 affected195 at risk
Lymphocytosis	Blood and lymphatic system disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00110 affected195 at risk
Atrial Fibrillation	Cardiac disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00119 affected195 at risk
Dry Eye	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG00010 affected191 at risk EG00133 affected195 at risk
Vision Blurred	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0006 affected191 at risk EG00130 affected195 at risk
Lacrimation Increased	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00127 affected195 at risk
Cataract	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00126 affected195 at risk
Visual Acuity Reduced	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG00119 affected195 at risk
Eye Irritation	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00117 affected195 at risk
Eye Pain	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00115 affected195 at risk
Photophobia	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG00114 affected195 at risk
Vitreous Floaters	Eye disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00114 affected195 at risk
Diarrhoea	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG00033 affected191 at risk EG001120 affected195 at risk
Nausea	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG00038 affected191 at risk EG00169 affected195 at risk
Constipation	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG00019 affected191 at risk EG00145 affected195 at risk
Vomiting	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG00011 affected191 at risk EG00139 affected195 at risk
Abdominal Pain	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG00019 affected191 at risk EG00130 affected195 at risk
Stomatitis	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00130 affected195 at risk
Dyspepsia	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0006 affected191 at risk EG00122 affected195 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00121 affected195 at risk
Dry Mouth	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG00119 affected195 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00116 affected195 at risk
Flatulence	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00110 affected195 at risk
Haemorrhoids	Gastrointestinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00110 affected195 at risk
Fatigue	General disorders	MeDRA 21.0	Non-systematic Assessment	EG00057 affected191 at risk EG00182 affected195 at risk
Pyrexia	General disorders	MeDRA 21.0	Non-systematic Assessment	EG00027 affected191 at risk EG00166 affected195 at risk
Oedema Peripheral	General disorders	MeDRA 21.0	Non-systematic Assessment	EG00016 affected191 at risk EG00146 affected195 at risk
Asthenia	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0008 affected191 at risk EG00122 affected195 at risk
Chills	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0006 affected191 at risk EG00116 affected195 at risk
Influenza Like Illness	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00116 affected195 at risk
Malaise	General disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG00110 affected195 at risk
Upper Respiratory Tract Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG00017 affected191 at risk EG00177 affected195 at risk
Sinusitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG00012 affected191 at risk EG00150 affected195 at risk
Urinary Tract Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG00010 affected191 at risk EG00146 affected195 at risk
Bronchitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00128 affected195 at risk
Nasopharyngitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0007 affected191 at risk EG00122 affected195 at risk
Conjunctivitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00121 affected195 at risk
Pneumonia	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00121 affected195 at risk
Cellulitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00115 affected195 at risk
Lower Respiratory Tract Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00115 affected195 at risk
Herpes Zoster	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00114 affected195 at risk
Ear Infection	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00113 affected195 at risk
Folliculitis	Infections and infestations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00110 affected195 at risk
Contusion	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0006 affected191 at risk EG00138 affected195 at risk
Fall	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG00118 affected195 at risk
Traumatic Haematoma	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00112 affected195 at risk
Infusion Related Reaction	Injury, poisoning and procedural complications	MeDRA 21.0	Non-systematic Assessment	EG00064 affected191 at risk EG0010 affected195 at risk
Weight Decreased	Investigations	MeDRA 21.0	Non-systematic Assessment	EG00011 affected191 at risk EG00125 affected195 at risk
Blood Creatinine Increased	Investigations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00112 affected195 at risk
Platelet Count Decreased	Investigations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00111 affected195 at risk
Weight Increased	Investigations	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00111 affected195 at risk
Decreased Appetite	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG00016 affected191 at risk EG00132 affected195 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG00122 affected195 at risk
Hypokalaemia	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00122 affected195 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0006 affected191 at risk EG00116 affected195 at risk
Hyponatraemia	Metabolism and nutrition disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00112 affected195 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG00014 affected191 at risk EG00153 affected195 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG00016 affected191 at risk EG00146 affected195 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG00014 affected191 at risk EG00139 affected195 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0009 affected191 at risk EG00129 affected195 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0007 affected191 at risk EG00124 affected195 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0009 affected191 at risk EG00120 affected195 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00110 affected195 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00110 affected195 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00110 affected195 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00118 affected195 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00113 affected195 at risk
Headache	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG00012 affected191 at risk EG00141 affected195 at risk
Dizziness	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG00010 affected191 at risk EG00133 affected195 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG00026 affected191 at risk EG00122 affected195 at risk
Paraesthesia	Nervous system disorders	MeDRA 21.0	Non-systematic Assessment	EG00010 affected191 at risk EG00114 affected195 at risk
Anxiety	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0009 affected191 at risk EG00118 affected195 at risk
Depression	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00117 affected195 at risk
Insomnia	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG00016 affected191 at risk EG00117 affected195 at risk
Confusional State	Psychiatric disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG00111 affected195 at risk
Pollakiuria	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00119 affected195 at risk
Dysuria	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG00112 affected195 at risk
Haematuria	Renal and urinary disorders	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00112 affected195 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG00043 affected191 at risk EG00178 affected195 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0009 affected191 at risk EG00133 affected195 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG00018 affected191 at risk EG00132 affected195 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00130 affected195 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0006 affected191 at risk EG00119 affected195 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0006 affected191 at risk EG00117 affected195 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG00114 affected195 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00114 affected195 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00110 affected195 at risk
Petechiae	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0002 affected191 at risk EG00128 affected195 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0007 affected191 at risk EG00126 affected195 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG00023 affected191 at risk EG00124 affected195 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00124 affected195 at risk
Rash Erythematous	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0009 affected191 at risk EG00120 affected195 at risk
Pruritus	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG00018 affected191 at risk EG00119 affected195 at risk
Rash	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0007 affected191 at risk EG00119 affected195 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0003 affected191 at risk EG00118 affected195 at risk
Actinic Keratosis	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0005 affected191 at risk EG00116 affected195 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00112 affected195 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00112 affected195 at risk
Blood Blister	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0001 affected191 at risk EG00110 affected195 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MeDRA 21.0	Non-systematic Assessment	EG0000 affected191 at risk EG00110 affected195 at risk
Hypertension	Vascular disorders	MeDRA 21.0	Non-systematic Assessment	EG0004 affected191 at risk EG00140 affected195 at risk

ID	Term
D012008	Recurrence
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D000092122	Bronchiolitis Obliterans Syndrome
D007938	Leukemia
D008223	Lymphoma

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D000092124	Organizing Pneumonia
D001989	Bronchiolitis Obliterans
D001988	Bronchiolitis
D001991	Bronchitis
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D006086	Graft vs Host Disease

ID	Title	Description
BG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
BG001	Ibrutinib (Arm B)	A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ofatumumab (Arm A)	An anti-CD20 monoclonal antibody ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity. Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)	16	191	59	191	185	191
EG001	Ibrutinib (Arm B)	A Bruton Tyrosine Kinase Inhibitor ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity	24	195	141	195	194	195