Evaluation of Safety of Pomalidomide in Combination With... | NCT01712789

NCT01712789

ID	Type	Description	Link
2012-001888-78	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pomalidomide plus Dexamethasone	Experimental	Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.	Drug: Pomalidomide Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Pomalidomide	Drug	Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle	Pomalidomide plus Dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAE)	An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs. A SAE = AE occurring at any dose that: Results in death; Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect	From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Overall Response	Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions

Eligibility Module

Name	Affiliation	Role
Teresa Peluso, MBBS, DCPSA	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz		A-8036	Austria
Medizinische Universitat Innsbruck

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27226434	Background	Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Rollig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.
28504846

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 30, 2013	Nov 25, 2020

Arm/Group Information

ID	Title	Description
BG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00065.4± 9.10

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000301
Male	BG000381

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00052
Not Hispanic or Latino	BG000626

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG0003
Black or African American	BG0004

Eastern Cooperative Oncology Group (ECOG) Performance Status

ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
0 = Fully active, no restrictions	BG000295
1 = Restricted activity but ambulatory

Time since diagnosis

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0006.15± 3.649

Beta 2 Microglobulin

This test measures the amount of a protein called beta-2 microglobulin (B2M) in the blood.

Mean

Standard Deviation

mg/L

Title

Denominators

Categories

Title	Measurements
	BG0005.48± 4.713

Serum Light Chain Type

Light chains are proteins made by plasma cells and make immunoglobulins (antibodies). Immunoglobulins help protect the body against illness and infections. Immunoglobulins are formed when light chains link up with heavy chains, another type of protein. There are two types of light chains: lambda and kappa light chains. A free light chains test measures the amount of lambda and kappa free light chains in the blood. If the amount of free light chains is higher or lower than normal, it can mean you have a disorder of the plasma cells.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Kappa	BG000364
Lambda	BG000

Serum Heavy Chain Type

Immunoglobulins help protect the body against illness and infections. Immunoglobulins are formed when light chains link up with heavy chains, another type of protein.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Immunoglobulin A (IgA)	BG000145
Immunoglobulin D (IgD)	BG000

Renal Function (Cockcroft Gault Creatinine Clearance)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
< 30 mL/min	BG00012
30 - < 45 mL/min	BG000

Corrected Serum Calcium

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0002.43± 0.231

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

Number of Participants With Treatment Emergent Adverse Events (TEAE)

An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.

A SAE = AE occurring at any dose that:

Results in death;
Is life-threatening
Requires inpatient hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect

The safety population includes all enrolled participants who received at least one dose of the IP.

Posted

Count of Participants

Participants

From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Units	Counts
Participants	OG000676

Title

Denominators

Categories

≥ TEAE

Title	Measurements
	OG000673

≥ 1 TEAE Related to Pomalidomide (POM)

Title	Measurements
	OG000527

≥ 1 TEAE Related to LD-Dex

Secondary

Overall Response

Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions

The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.

Posted

Number

95% Confidence Interval

Percentage of Participants

Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Secondary

Time to Response

Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria.

Includes participants with a response (sCR, VGPR or PR).

Posted

Median

Full Range

Weeks

Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Units	Counts
Participants	OG000

Secondary

Kaplan Meier Estimate of Duration of Response

Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.

Includes participants with a response (sCR, VGPR or PR).

Posted

Median

95% Confidence Interval

Months

From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Units	Counts
Participants

Secondary

Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines

Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.

Posted

Median

95% Confidence Interval

Months

From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Secondary

Kaplan Meier Estimate of Time to Progression

Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted).

Posted

Median

95% Confidence Interval

Months

From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Units

Secondary

Kaplan Meier Estimate of Overall Survival (OS)

Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive.

Posted

Median

95% Confidence Interval

Months

From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Units	Counts
Participants

Secondary

Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)

Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.

Pharmacokinetic population

Pharmacokinetic samples from 476 participants included in studies CC-4047-MM-005 and CC 4047 MM 010 were used for the population PK analysis of pomalidomide

Posted

Median

95% Confidence Interval

Liters/hour

Cycles 1, 2, 3, 4, 5, 6

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Units	Counts
Participants	OG000

Secondary

Pomalidomide Exposure - Apparent Volume of Distribution (V/F)

Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.

Pharmacokinetic population

Pharmacokinetic samples from 476 participants included in studies CC-4047-MM-005 and CC 4047 MM 010 were used for the population PK analysis of pomalidomide

Posted

Median

95% Confidence Interval

Liters

Cycles 1, 2, 3, 4, 5, 6

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Units	Counts
Participants	OG000

Secondary

Cytogenetic Analysis

Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome.

Statistical analysis could not be performed due to high level of missing cytogenetic data as well as cytogenetic probe analysis being non- compliant with study requirements which lead to an inability to accurately identify specific cytogenetic abnormalities.

Posted

Study entry

ID	Title	Description
OG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)	Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.	598	682	448	676	646	676

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00015 affected676 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00034 affected676 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hyperviscosity syndrome	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00020 affected676 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00013 affected676 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Angina pectoris	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG00017 affected676 at risk
Atrial flutter	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Atrioventricular block	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Cardiac amyloidosis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Cardiac arrest	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Cardiac disorder	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG00012 affected676 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Palpitations	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Exophthalmos	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected676 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Gastrointestinal amyloidosis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Ileus	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Rectal ulcer	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Volvulus	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Death	General disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Disease progression	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Euthanasia	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
General physical health deterioration	General disorders	MedDRA 22.0	Systematic Assessment	EG00045 affected676 at risk
Generalised oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hyperpyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Hyperthermia	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Malaise	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Mucosal inflammation	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Non-cardiac chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Oedema	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG00041 affected676 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Gallbladder obstruction	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Abdominal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Abscess limb	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Anal abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Appendicitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Arthritis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Atypical pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Biliary sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0009 affected676 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Bursitis infective	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Catheter site infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Cerebral aspergillosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Citrobacter infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Clostridial sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Cystitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Device related infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Diverticulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Ear infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Erysipelas	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Escherichia infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Escherichia sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Folliculitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Herpes zoster infection neurological	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00014 affected676 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Leishmaniasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Listeria sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Listeriosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Localised infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00022 affected676 at risk
Lung infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00016 affected676 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Meningococcal sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Oral fungal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Oral infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Osteomyelitis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Otitis externa	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG000117 affected676 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Pneumonia viral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Respiratory moniliasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00011 affected676 at risk
Rhinovirus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00014 affected676 at risk
Septic shock	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00015 affected676 at risk
Sinusitis bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Soft tissue infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Staphylococcal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Streptococcal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Systemic candida	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Systemic infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Tracheobronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0008 affected676 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00011 affected676 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Urosepsis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Vascular device infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Febrile nonhaemolytic transfusion reaction	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Ilium fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Perineal injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0006 affected676 at risk
Blood immunoglobulin A increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
C-reactive protein increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
International normalised ratio increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Monoclonal immunoglobulin present	Investigations	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Neutrophil count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Platelet count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Protein urine present	Investigations	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
White blood cell count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hyperamylasaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00030 affected676 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected676 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected676 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0007 affected676 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0006 affected676 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG00010 affected676 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0007 affected676 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Cognitive disorder	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Coma	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Disturbance in attention	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Encephalopathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Facial nerve disorder	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
IIIrd nerve paresis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Lateral medullary syndrome	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Motor dysfunction	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Paraesthesia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Paraplegia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Parkinsonism	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Presyncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Seizure	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Somnolence	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Spinal cord compression	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected676 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Syncope	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Confusional state	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Depression	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Disorientation	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG00026 affected676 at risk
Crush syndrome	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Haematuria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Oliguria	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Renal failure	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG00023 affected676 at risk
Renal impairment	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Renal vascular thrombosis	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Urinary retention	Renal and urinary disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Scrotal cyst	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG00015 affected676 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected676 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected676 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0005 affected676 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG00014 affected676 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Social stay hospitalisation	Social circumstances	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Aortic stenosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected676 at risk
Haematoma	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hypertension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk
Hypotension	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected676 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected676 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG000327 affected676 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG00092 affected676 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG000382 affected676 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 22.0	Systematic Assessment	EG000236 affected676 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00034 affected676 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG000163 affected676 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG000118 affected676 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00096 affected676 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00049 affected676 at risk
Asthenia	General disorders	MedDRA 22.0	Systematic Assessment	EG000155 affected676 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG000197 affected676 at risk
Oedema peripheral	General disorders	MedDRA 22.0	Systematic Assessment	EG000108 affected676 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG000178 affected676 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00070 affected676 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00057 affected676 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00038 affected676 at risk
Respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00058 affected676 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00050 affected676 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00054 affected676 at risk
Blood creatinine increased	Investigations	MedDRA 22.0	Systematic Assessment	EG00049 affected676 at risk
C-reactive protein increased	Investigations	MedDRA 22.0	Systematic Assessment	EG00034 affected676 at risk
Neutrophil count decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG00047 affected676 at risk
Weight decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG00047 affected676 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00069 affected676 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00040 affected676 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00040 affected676 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG00052 affected676 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00042 affected676 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG000105 affected676 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00065 affected676 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00096 affected676 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00035 affected676 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00054 affected676 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00037 affected676 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG00054 affected676 at risk
Dizziness	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG00055 affected676 at risk
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG00049 affected676 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG00079 affected676 at risk
Tremor	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG00045 affected676 at risk
Confusional state	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG00037 affected676 at risk
Insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG00076 affected676 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG000141 affected676 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG000117 affected676 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG00047 affected676 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG00037 affected676 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG00036 affected676 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG00054 affected676 at risk

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D009101	Multiple Myeloma
D012008	Recurrence

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated