IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Place... | NCT01850524

ID	Type	Description
2013-000326-54	EudraCT Number
U1111-1158-2646	Registry Identifier	WHO
163325	Registry Identifier	HC-CTD

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo + LenDex	Placebo Comparator	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).	Drug: Placebo Drug: Dexamethasone Drug: Lenalidomide
Active Comparator: Ixazomib + LenDex	Active Comparator	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).	Drug: Ixazomib Drug: Dexamethasone Drug: Lenalidomide

Name	Type	Description	Arm Group Labels	Other Names
Ixazomib	Drug	IXAZOMIB capsules.	Active Comparator: Ixazomib + LenDex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause according to International Myeloma Working Group (IMWG) criteria whichever occurs first. PD required one of the following: Increase of >=25% from nadir in: Serum M-component and/or (the absolute increase must be >=0.5 g/dL); Urine M-component and/or (the absolute increase must be >=200 mg/24 hours); in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be > 10 mg/dL); Bone marrow plasma cell percentage: the absolute % must be >10%; development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.85 mmol/L).	Up to approximately 79 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis are censored at the date last known to be alive.	From the date of randomization to death due to any cause (Up to approximately 9 years)
Complete Response (CR) Rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants 18 years or older diagnosed with Multiple Myeloma according to standard criteria who have not received prior treatment for multiple myeloma.
Participants for whom lenalidomide and dexamethasone treatment is appropriate and who are not eligible for high-dose therapy followed by stem-cell transplantation (HDT-SCT) for 1 or more of the following reasons:
- The participant is 65 years of age or older.
- The participant is less than 65 years of age but has significant comorbid condition(s) that are, in the opinion of the investigator, likely to have a negative impact on tolerability of HDT-SCT.
Measurable disease as specified in study protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Meet the clinical laboratories criteria as specified in the protocol.
Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, and must also agree to ongoing pregnancy testing; must also adhere to the guidelines of the lenalidomide pregnancy prevention program.
Male participants who agree to practice effective barrier contraception or agree to practice true abstinence AND must adhere to the guidelines of the lenalidomide pregnancy prevention program.
Suitable venous access for the study-required blood sampling.
Must be able to take concurrent aspirin 70 mg to 325 mg daily (or enoxaparin if aspirin allergic).
Voluntary written consent.
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

Prior treatment for multiple myeloma with either standard of care treatment or investigational regimen.
Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Inability or unwillingness to receive antithrombotic therapy.
Female participants who are lactating or pregnant.
Major surgery or radiotherapy within 14 days before randomization.
Infection requiring intravenous antibiotics within 14 days before the first dose of study drug.
Central nervous system involvement.
Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.
Evidence of current uncontrolled cardiovascular conditions within 6 months prior to randomization, including: Uncontrolled hypertension, cardiac arrhythmias, or congestive heart failure; Unstable angina, or Myocardial infarction.
Systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin,itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the study.
Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (e.g., peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause).
Psychiatric illness/social situation that would limit compliance with study requirements.
Known allergy to any of the study medications.
Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.
Treatment with any investigational products within 60 days before randomization.

Name	Affiliation	Role
Medical Director Clinical Science	Millennium Pharmaceuticals, Inc.	Study Director

PubMed Identifier	Type	Citation	Retractions
33763699	Derived	Facon T, Venner CP, Bahlis NJ, Offner F, White DJ, Karlin L, Benboubker L, Rigaudeau S, Rodon P, Voog E, Yoon SS, Suzuki K, Shibayama H, Zhang X, Twumasi-Ankrah P, Yung G, Rifkin RM, Moreau P, Lonial S, Kumar SK, Richardson PG, Rajkumar SV. Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2021 Jul 1;137(26):3616-3628. doi: 10.1182/blood.2020008787.

Label	URL
Related Info	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

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	Jul 9, 2020	Nov 20, 2020

Arm/Group Information

ID	Title	Description
BG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
BG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
BG002	Total	Total of all reporting groups

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
	OG00021.8(19.65 to 30.78) OG00135.3(26.45 to 43.70)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	Log-rank test is stratified by age (<75 years vs >=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (<4 vs >=4) at screening.	0.073		Hazard Ratio (HR)	0.830			2-Sided	95	0.676	1.018					Superiority

Secondary

Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis are censored at the date last known to be alive.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

From the date of randomization to death due to any cause (Up to approximately 9 years)

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Complete Response (CR) Rate

CR rate was defined as the percentage of participants who achieve CR assessed by an IRC relative to the intent-to-treat (ITT) population during the treatment period. Percentage of participants with CR, as assessed by IMWG disease assessment criteria were reported. CR was defined as negative immunofixation of serum and urine along with the disappearance of any soft tissue plasmacytomas and <5 % plasma cells (PC's) in bone marrow.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Pain Response Rate as Assessed by the Brief Pain Inventory- Short Form (BPI-SF) and Analgesic Use

Pain response rate was defined as percentage of participants with pain response. Pain response was defined as the occurrence of at least a 30% reduction from baseline in BPI-SF worst pain score over the last 24 hours without an increase in analgesic use for 2 consecutive measurements > 28 days apart, were reported. Brief Pain Inventory - Short Form (m-BPI-SF) is a participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Percentages are rounded off to the nearest single decimal.

ITT population included all participants who were randomized. Overall number of participants analyzed are the number of participants with baseline worst pain score>=4 as assessed by m-BPI-SF.

Posted

Number

percentage of participants

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001

Secondary

Overall Response Rate (ORR)

ORR was defined as the percentage of participants who achieved CR + partial response (PR) + very good partial response (VGPR) (including sCR) or better relative to the ITT population during treatment period. CR was defined as negative immunofixation of serum and urine along with the disappearance of any soft tissue plasmacytomas and <5 % PC's in bone marrow. PR was defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% along with ≥50% reduction in the size of soft tissue plasmacytomas. VGPR was defined as ≥90% in serum M-component plus urine M-component <100 mg/24. sCR is defined as stringent complete response. Percentages are rounded off to nearest whole numbers.

ITT population included all participants who were randomized.

Posted

Number

percentage of participants

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001

Secondary

Time to Response

Time to response was defined as the time from the date of randomization to the first documentation of PR or better, as measured by IMWG criteria.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Duration of Response

Duration of response was measured as the time from the date of first documentation of PR or better to the date of first documented progression (PD) for responders, as measured by IMWG criteria.

Response-evaluable population was defined as all participants in the ITT population who receive at least 1 dose of any study drug, have measurable disease at baseline, and at least 1 post baseline response assessment assessed by an IRC. Overall number of participants analyzed are the number of responders.

Posted

Median

95% Confidence Interval

months

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Time to Progression (TTP)

Time to progression was defined as the time from randomization to the date of first documented disease progression.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Progression Free Survival (PFS)-2

PFS2 was defined as the time from the date of randomization to the date of documentation of disease progression on the subsequent line of anticancer therapy, as assessed by the investigator in accordance with IMWG criteria, or death due to any cause, whichever occurs first.

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Number of Participants With Shifts From Baseline to Worst Value in Eastern Cooperative Oncology Group (ECOG) Performance Score

Eastern Cooperative Oncology Group (ECOG) scale score ranged from 0 to 5, where 0 indicated normal activity and 5 indicated death. The data is reported for those categories where at least 1 participant had worst post-baseline value for each ECOG score.

Safety population is defined as all participants who receive at least 1 dose of any study drug. Overall number of participants analyzed indicates number of participants available for analysis.

Posted

Count of Participants

Participants

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.

Safety population is defined as all participants who receive at least 1 dose of any study drug. Data for safety is summarized as per the duration of exposure to study treatment (exposure up to 18 cycles; exposure ≥19 cycles).

Posted

Count of Participants

Participants

From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)

ID	Title	Description
OG000	Placebo + LenDex (Exposure Up to 18 Cycles)	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).

Secondary

Number of Participants With Abnormal Serum Chemistry and Hematology Laboratory Values Based on Treatment-emergent Adverse Events (TEAEs)

The laboratory values assessment included serum chemistry and hematology. The Serum chemistry assessment included blood urea nitrogen (BUN), creatinine, bilirubin (total), urate, lactate dehydrogenase, phosphate, albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), glucose, sodium, potassium, calcium, chloride, carbon dioxide (CO2), magnesium, thyroid stimulating hormone (TSH). Hematology assessment included hemoglobin, hematocrit, platelet (count), leukocytes with differential neutrophils (ANC). Participants with abnormal serum chemistry laboratory values reported as TEAEs are reported. TEAEs were defined as events that occurred after administration of the first dose of any agent in the study drug regimen and through 30 days after the last dose of any agent in the study drug regimen.

Posted

Count of Participants

Participants

From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)

ID	Title	Description
OG000	Placebo + LenDex (Exposure Up to 18 Cycles)	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).

Secondary

Change From Baseline in Health-Related Quality of Life (HRQOL) Measured by European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ)-C30 Scale Total Score

EORTC-QLQ-C30 scale was used to assess HRQOL in cancer participants and contains 30 items. Subscale with individual items include physical functioning items 1-5, role functioning items 6-7, emotional functioning items 21-24, cognitive functioning items 20, 25, social functioning items 26-27, quality of life items 29-30, fatigue items 10, 12, 18, nausea and vomiting items 14-15, pain items 9, 19, dyspnoea item 8, insomnia item 11, appetite loss item 13, constipation item 16, diarrhoea item 17, financial difficulties item 28. Raw scores were converted into scale scores ranging from 0 to 100. For the functional scales and the global health status scale, higher scores represent better HRQOL; whereas for the symptom scales lower scores represent better HRQOL. Positive change in functional and global health status scale indicated improvement; negative change for the symptom scales indicates improvement.

ITT population included all participants who were randomized. Overall number of participants analyzed is the number of participants available for analyses. Number analyzed indicates the number of participants available for analysis at the given timepoint.

Posted

Mean

Standard Deviation

score on a scale

Baseline to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Change From Baseline in HRQOL Measured by EORTC-QLQ-MY20 Scale

EORTC QLQ-MY20 was a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. The scale has 20 questions. Subscale and individual items include future perspective items 18-20, body image item 17, disease symptoms items 1-6, side effects of treatment items 7-16. Raw scores are averaged, and transformed to 0-100 scale, where higher score is better quality of life. Positive change indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex

Secondary

OS in High-risk Population Carrying Del(17p), t(4;14), or t(14;16) Mutations

OS was defined as the time from the date of randomization to the date of death, as assessed in high-risk population carrying del(17p), t(4;14), or t(14;16) mutations. High risk category includes t(4;14), t(14;16), or del(17) abnormalities.

ITT population included all participants who were randomized. Overall number of participants analyzed indicates the number of participants from the high-risk category.

Posted

Median

95% Confidence Interval

months

From the date of randomization to death due to any cause (Up to approximately 9 years)

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

PFS in High-risk Population Carrying Del(17p), t(4;14), or t(14;16) Mutations

PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease based on central laboratory results and IMWG criteria as evaluated by an independent review committee (IRC) or death due to any cause, whichever occurs first, as assessed in high-risk population carrying del(17p), t(4;14), or t(14;16) mutations.

ITT population included all participants who were randomized. Overall number of participants analyzed indicates the number of participants from the high-risk category.

Posted

Median

95% Confidence Interval

months

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Percentage of Participants With MRD-Negative Status as Assessed by Flow Cytometry

The absence of minimal residual disease (MRD negativity) was tested in all participants who achieve a CR and maintained it until Cycle 18, using bone marrow aspirates.

Response-evaluable population includes all participants in the ITT population who receive at least 1 dose of any study drug, have measurable disease at baseline, and at least 1 post baseline response assessment assessed by an IRC. Percentages are rounded off to the nearest single decimal.

Posted

Number

percentage of participants

Up to Cycle 18 (cycle length = 28 days)

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001	Ixazomib + LenDex	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Secondary

Time to Pain Progression

Time to pain progression was assessed as the time from randomization to the date of initial progression classification. Pain progression was defined as the occurrence of 1 of the following and confirmed by 2 consecutive evaluations (To qualify as progression, the participant must have a BPI-SF worst pain score > 4 during pain progression): 1) a ≥ 2 point and 30% increase from Baseline in BPI-SF worst pain score without an increase in analgesic use, or 2) a 25% or more increase in analgesic use from Baseline without a decrease in BPI-SF worst pain score from Baseline. Brief Pain Inventory - Short Form (m-BPI-SF) is a participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).

ITT population included all participants who were randomized.

Posted

Median

95% Confidence Interval

months

Up to approximately 9 years

ID	Title	Description
OG000	Placebo + LenDex	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
OG001

Secondary

Cmax: Maximum Plasma Concentration for Ixazomib

Pharmacokinetic (PK) analysis population is defined as subjects with at least one PK sample that was collected and analyzed. Overall number of participants analyzed is the number of participants available for analyses. Number analyzed indicates the number of participants available for analysis at the given timepoint.

Posted

Mean

Standard Deviation

nanograms per milliliter

Cycle 1 Day 1: Post-dose at multiple timepoints up to 4 hours; Pre-dose at Cycle 1 Day 14, Cycles 2-3 Day 1 and Day 14, Cycles 4-11 Day 1 (Each cycle length = 28 days)

ID	Title	Description
OG000	Ixazomib	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsules orally once on Days 1,8,15 and lenalidomide 25 mg capsules orally on days 1-21 and dexamethasone 40 mg tablets orally on Days 1,8, 15 and 22, during every 28-day cycle for the first 18 cycles. After Cycle 18 dexamethasone was discontinued and participants continued to receive ixazomib capsule and lenalidomide at reduced doses until progressive disease or unacceptable toxicity, whichever comes first, up to end of study (up to approximately 109 months).

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With New or Worsening of Existing Skeletal-related Events (SREs)

SRE is defined as new fractures [including vertebral compression fractures], irradiation of or surgery on bone, or spinal cord compression.

Posted

Number

percentage of partcipants

From the date of randomization through 30 days after the last dose of study drug up to end of study (up to approximately 9 years)

ID	Title	Description
OG000	Placebo + LenDex (Exposure Up to 18 Cycles)	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).
OG001	Ixazomib+ LenDex (Exposure Up to 18 Cycles)	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).

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	Placebo + LenDex (Exposure Up to 18 Cycles)	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).	107	160	105	160	159	160
EG001	Ixazomib+ LenDex (Exposure Up to 18 Cycles)	Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days).	95	163	119	163	162	163
EG002	Placebo + LenDex (Exposure ≥19 Cycles)	Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib placebo matching capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).	63	189	119	189	189	189
EG003	Ixazomib + LenDex (Exposure ≥19 Cycles)	Participants who were randomly assigned to receive Ixazomib 4.0 mg placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) up to 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).	63	191	125	191	191	191

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG00016 affected160 at risk EG00122 affected163 at risk EG00213 affected189 at risk EG00322 affected191 at risk
Bronchitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0013 affected163 at risk EG0025 affected189 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Pleural infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Sepsis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0014 affected163 at risk EG0024 affected189 at risk EG003
Septic shock	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0014 affected163 at risk EG0020 affected189 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Urosepsis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0013 affected163 at risk EG0023 affected189 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Cellulitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0011 affected163 at risk EG0022 affected189 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Cystitis bacterial	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Superinfection bacterial	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0014 affected163 at risk EG0022 affected189 at risk EG003
Diverticulitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Appendicitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Peritonitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0013 affected163 at risk EG0021 affected189 at risk EG003
Toxic shock syndrome staphylococcal	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Influenza	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0011 affected163 at risk EG0023 affected189 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Herpes zoster	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Lower respiratory tract infection viral	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Viral uveitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Erysipelas	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Tonsillitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Bursitis infective	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Abscess jaw	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Pneumonia parainfluenzae viral	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Sinusitis aspergillus	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Prostatitis Escherichia coli	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Pneumonia haemophilus	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Device related infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Endocarditis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Meningitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Tooth infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Bartholinitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Fungal oesophagitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hepatitis E	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Pseudomonal sepsis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0012 affected163 at risk EG0026 affected189 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0024 affected189 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0013 affected163 at risk EG0021 affected189 at risk EG003
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Lung carcinoma cell type unspecified stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Sarcomatoid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Large granular lymphocytosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0018 affected163 at risk EG0021 affected189 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0012 affected163 at risk EG0021 affected189 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Rectal prolapse	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Periodontal disease	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Gastric volvulus	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
General physical health deterioration	General disorders	MedDRA: 22.0	Systematic Assessment	EG0005 affected160 at risk EG0015 affected163 at risk EG0022 affected189 at risk EG003
Influenza like illness	General disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Pyrexia	General disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0013 affected163 at risk EG0023 affected189 at risk EG003
Sudden death	General disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Death	General disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Asthenia	General disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Malaise	General disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Fatigue	General disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Pain	General disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Chest pain	General disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Oedema peripheral	General disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Generalised oedema	General disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Stent-graft endoleak	General disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hyperthermia	General disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Complication associated with device	General disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Incarcerated hernia	General disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0012 affected163 at risk EG0021 affected189 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Cerebral haematoma	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Thalamic infarction	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Thalamus haemorrhage	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Syncope	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0014 affected163 at risk EG0026 affected189 at risk EG003
Lethargy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Epilepsy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Seizure	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0012 affected163 at risk EG0022 affected189 at risk EG003
Presyncope	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG00027 affected160 at risk EG00123 affected163 at risk EG00257 affected189 at risk EG003
Spinal claudication	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Demyelinating polyneuropathy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Hepatic encephalopathy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Peroneal nerve palsy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Hemiplegia	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0013 affected163 at risk EG0021 affected189 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0005 affected160 at risk EG0011 affected163 at risk EG0022 affected189 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0013 affected163 at risk EG0023 affected189 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0023 affected189 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0012 affected163 at risk EG0020 affected189 at risk EG003
Angina unstable	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0022 affected189 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0014 affected163 at risk EG0020 affected189 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0012 affected163 at risk EG0020 affected189 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0007 affected160 at risk EG0014 affected163 at risk EG0025 affected189 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0013 affected163 at risk EG0021 affected189 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0015 affected163 at risk EG0020 affected189 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0012 affected163 at risk EG0021 affected189 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0012 affected163 at risk EG0022 affected189 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0012 affected163 at risk EG0022 affected189 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0005 affected160 at risk EG0017 affected163 at risk EG00220 affected189 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0012 affected163 at risk EG0020 affected189 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Crystal arthropathy	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Sarcopenia	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0022 affected189 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0024 affected189 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0023 affected189 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0022 affected189 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Aortic injury	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG00011 affected160 at risk EG00110 affected163 at risk EG0025 affected189 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG00045 affected160 at risk EG00134 affected163 at risk EG00235 affected189 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0011 affected163 at risk EG0021 affected189 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0012 affected163 at risk EG0020 affected189 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0012 affected163 at risk EG0022 affected189 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0014 affected163 at risk EG0020 affected189 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0012 affected163 at risk EG0020 affected189 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0012 affected163 at risk EG0020 affected189 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0012 affected163 at risk EG0020 affected189 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0008 affected160 at risk EG0015 affected163 at risk EG0022 affected189 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Nephritis	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0015 affected163 at risk EG0022 affected189 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0014 affected163 at risk EG0022 affected189 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0014 affected163 at risk EG0021 affected189 at risk EG003
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0012 affected163 at risk EG0025 affected189 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Hypotension	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0022 affected189 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Phlebitis	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0022 affected189 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Confusional state	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0025 affected189 at risk EG003
Delirium	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Depression	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Anxiety	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Hallucination	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Obsessive thoughts	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Platelet count decreased	Investigations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
International normalised ratio increased	Investigations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Weight decreased	Investigations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Staphylococcus test positive	Investigations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Blast cells present	Investigations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Blood creatinine increased	Investigations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Angle closure glaucoma	Eye disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Optic nerve sheath haemorrhage	Eye disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Amaurosis	Eye disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Cataract	Eye disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0023 affected189 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Testicular oedema	Reproductive system and breast disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0022 affected189 at risk EG003
Device breakage	Product Issues	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Device loosening	Product Issues	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Embolism	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Thrombosis	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Pharyngitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Skin infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Fracture displacement	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Subdural Heamatoma	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Acute erythroid leukemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Myeloma cast nephropathy	Renal and urinary disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Pneumonitis aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Fracture pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0010 affected163 at risk EG0020 affected189 at risk EG003
Inflammation	General disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Senile dementia	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0020 affected189 at risk EG003
Prosthetic cardiac valve malfunction	Product Issues	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0021 affected189 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oedema peripheral	General disorders	MedDRA: 22.0	Systematic Assessment	EG00052 affected160 at risk EG00166 affected163 at risk EG00264 affected189 at risk EG003106 affected191 at risk
Fatigue	General disorders	MedDRA: 22.0	Systematic Assessment	EG00053 affected160 at risk EG00141 affected163 at risk EG00252 affected189 at risk EG003
Asthenia	General disorders	MedDRA: 22.0	Systematic Assessment	EG00044 affected160 at risk EG00136 affected163 at risk EG00253 affected189 at risk EG003
Pyrexia	General disorders	MedDRA: 22.0	Systematic Assessment	EG00020 affected160 at risk EG00130 affected163 at risk EG00229 affected189 at risk EG003
Peripheral swelling	General disorders	MedDRA: 22.0	Systematic Assessment	EG0008 affected160 at risk EG0018 affected163 at risk EG00212 affected189 at risk EG003
Malaise	General disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0016 affected163 at risk EG00216 affected189 at risk EG003
Influenza like illness	General disorders	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0011 affected163 at risk EG00211 affected189 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0014 affected163 at risk EG00210 affected189 at risk EG003
Chills	General disorders	MedDRA: 22.0	Systematic Assessment	EG00010 affected160 at risk EG00111 affected163 at risk EG0027 affected189 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG00048 affected160 at risk EG00168 affected163 at risk EG002115 affected189 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG00061 affected160 at risk EG00159 affected163 at risk EG00282 affected189 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG00035 affected160 at risk EG00155 affected163 at risk EG00263 affected189 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG00013 affected160 at risk EG00141 affected163 at risk EG00233 affected189 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG00014 affected160 at risk EG00111 affected163 at risk EG00212 affected189 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0009 affected160 at risk EG00110 affected163 at risk EG0028 affected189 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG00013 affected160 at risk EG0018 affected163 at risk EG00229 affected189 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG00010 affected160 at risk EG0017 affected163 at risk EG00238 affected189 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG00016 affected160 at risk EG0015 affected163 at risk EG00222 affected189 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG0011 affected163 at risk EG00215 affected189 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0014 affected163 at risk EG00210 affected189 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG0011 affected163 at risk EG00211 affected189 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0013 affected163 at risk EG00215 affected189 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG00210 affected189 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00018 affected160 at risk EG00137 affected163 at risk EG00222 affected189 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00013 affected160 at risk EG00116 affected163 at risk EG00229 affected189 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0008 affected160 at risk EG00111 affected163 at risk EG00222 affected189 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG00111 affected163 at risk EG00211 affected189 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG00111 affected163 at risk EG00220 affected189 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0009 affected160 at risk EG00111 affected163 at risk EG0027 affected189 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0009 affected160 at risk EG0019 affected163 at risk EG0029 affected189 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0008 affected160 at risk EG0018 affected163 at risk EG0024 affected189 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00010 affected160 at risk EG0016 affected163 at risk EG0023 affected189 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0013 affected163 at risk EG0028 affected189 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0012 affected163 at risk EG0025 affected189 at risk EG003
Dizziness	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG00031 affected160 at risk EG00127 affected163 at risk EG00236 affected189 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG00027 affected160 at risk EG00123 affected163 at risk EG00257 affected189 at risk EG003
Headache	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG00022 affected160 at risk EG00115 affected163 at risk EG00236 affected189 at risk EG003
Tremor	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG00023 affected160 at risk EG00114 affected163 at risk EG00227 affected189 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG00014 affected160 at risk EG0019 affected163 at risk EG00212 affected189 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG00013 affected160 at risk EG0019 affected163 at risk EG00221 affected189 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0007 affected160 at risk EG0016 affected163 at risk EG00211 affected189 at risk EG003
Sciatica	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0014 affected163 at risk EG00211 affected189 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0012 affected163 at risk EG0029 affected189 at risk EG003
Syncope	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0026 affected189 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG00014 affected160 at risk EG00119 affected163 at risk EG00227 affected189 at risk EG003
Bronchitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG00013 affected160 at risk EG00113 affected163 at risk EG00251 affected189 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG00013 affected160 at risk EG00113 affected163 at risk EG00271 affected189 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG00017 affected160 at risk EG00110 affected163 at risk EG00247 affected189 at risk EG003
Herpes zoster	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0014 affected163 at risk EG0024 affected189 at risk EG003
Rhinitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0005 affected160 at risk EG0012 affected163 at risk EG00221 affected189 at risk EG003
Pneumonia	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG0017 affected163 at risk EG00220 affected189 at risk EG003
Sinusitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0015 affected163 at risk EG0026 affected189 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0012 affected163 at risk EG0025 affected189 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0014 affected163 at risk EG00215 affected189 at risk EG003
Influenza	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0013 affected163 at risk EG00222 affected189 at risk EG003
Cystitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0012 affected163 at risk EG00212 affected189 at risk EG003
Cellulitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0005 affected160 at risk EG0012 affected163 at risk EG0023 affected189 at risk EG003
Pharyngitis	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0012 affected163 at risk EG00210 affected189 at risk EG003
Tooth infection	Infections and infestations	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0012 affected163 at risk EG00211 affected189 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00034 affected160 at risk EG00126 affected163 at risk EG00267 affected189 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00029 affected160 at risk EG00118 affected163 at risk EG00250 affected189 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00023 affected160 at risk EG00123 affected163 at risk EG00281 affected189 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00027 affected160 at risk EG00115 affected163 at risk EG00250 affected189 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00012 affected160 at risk EG00112 affected163 at risk EG00227 affected189 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00012 affected160 at risk EG0019 affected163 at risk EG00219 affected189 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG00214 affected189 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0009 affected160 at risk EG0017 affected163 at risk EG00225 affected189 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0009 affected160 at risk EG0015 affected163 at risk EG00224 affected189 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG00010 affected160 at risk EG0014 affected163 at risk EG00224 affected189 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0011 affected163 at risk EG00213 affected189 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0012 affected163 at risk EG0024 affected189 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0017 affected163 at risk EG00211 affected189 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG00220 affected189 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG00045 affected160 at risk EG00134 affected163 at risk EG00234 affected189 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG00016 affected160 at risk EG00133 affected163 at risk EG00233 affected189 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG00011 affected160 at risk EG00110 affected163 at risk EG0025 affected189 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG00110 affected163 at risk EG0027 affected189 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0019 affected163 at risk EG0023 affected189 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG00013 affected160 at risk EG0016 affected163 at risk EG00212 affected189 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0008 affected160 at risk EG0016 affected163 at risk EG00211 affected189 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0011 affected163 at risk EG00214 affected189 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0017 affected163 at risk EG00215 affected189 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA: 22.0	Systematic Assessment	EG00056 affected160 at risk EG00151 affected163 at risk EG00251 affected189 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA: 22.0	Systematic Assessment	EG00015 affected160 at risk EG00132 affected163 at risk EG00214 affected189 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA: 22.0	Systematic Assessment	EG00036 affected160 at risk EG00115 affected163 at risk EG00248 affected189 at risk EG003
Insomnia	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG00027 affected160 at risk EG00130 affected163 at risk EG00268 affected189 at risk EG003
Anxiety	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG00015 affected160 at risk EG00122 affected163 at risk EG00225 affected189 at risk EG003
Depression	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG00010 affected160 at risk EG00118 affected163 at risk EG00214 affected189 at risk EG003
Confusional state	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG00015 affected160 at risk EG00116 affected163 at risk EG00211 affected189 at risk EG003
Agitation	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0014 affected163 at risk EG00210 affected189 at risk EG003
Irritability	Psychiatric disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0011 affected163 at risk EG00211 affected189 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG00024 affected160 at risk EG00128 affected163 at risk EG00237 affected189 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG00032 affected160 at risk EG00121 affected163 at risk EG00226 affected189 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG0012 affected163 at risk EG0027 affected189 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG00011 affected160 at risk EG0017 affected163 at risk EG00216 affected189 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0007 affected160 at risk EG0018 affected163 at risk EG00214 affected189 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0013 affected163 at risk EG00212 affected189 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0008 affected160 at risk EG0012 affected163 at risk EG0025 affected189 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG0012 affected163 at risk EG00210 affected189 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0015 affected163 at risk EG00212 affected189 at risk EG003
Weight decreased	Investigations	MedDRA: 22.0	Systematic Assessment	EG00020 affected160 at risk EG00124 affected163 at risk EG00230 affected189 at risk EG003
Neutrophil count decreased	Investigations	MedDRA: 22.0	Systematic Assessment	EG00011 affected160 at risk EG0015 affected163 at risk EG00213 affected189 at risk EG003
Blood creatinine increased	Investigations	MedDRA: 22.0	Systematic Assessment	EG0008 affected160 at risk EG0016 affected163 at risk EG00212 affected189 at risk EG003
Platelet count decreased	Investigations	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG0016 affected163 at risk EG0024 affected189 at risk EG003
Hypertension	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0009 affected160 at risk EG0016 affected163 at risk EG00218 affected189 at risk EG003
Hypotension	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG00012 affected160 at risk EG00117 affected163 at risk EG00211 affected189 at risk EG003
Haematoma	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0012 affected163 at risk EG0027 affected189 at risk EG003
Flushing	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0005 affected160 at risk EG0014 affected163 at risk EG00212 affected189 at risk EG003
Hot flush	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG00214 affected189 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA: 22.0	Systematic Assessment	EG00015 affected160 at risk EG0015 affected163 at risk EG00213 affected189 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0019 affected163 at risk EG0020 affected189 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0008 affected160 at risk EG0016 affected163 at risk EG00211 affected189 at risk EG003
Palpitations	Cardiac disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0010 affected163 at risk EG0028 affected189 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0009 affected160 at risk EG0018 affected163 at risk EG00235 affected189 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0007 affected160 at risk EG0013 affected163 at risk EG00220 affected189 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0011 affected163 at risk EG00211 affected189 at risk EG003
Cataract	Eye disorders	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG0011 affected163 at risk EG00241 affected189 at risk EG003
Vision blurred	Eye disorders	MedDRA: 22.0	Systematic Assessment	EG0006 affected160 at risk EG0016 affected163 at risk EG00222 affected189 at risk EG003
Dry eye	Eye disorders	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0015 affected163 at risk EG0026 affected189 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0013 affected163 at risk EG00218 affected189 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA: 22.0	Systematic Assessment	EG0000 affected160 at risk EG0011 affected163 at risk EG0026 affected189 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA: 22.0	Systematic Assessment	EG0002 affected160 at risk EG0010 affected163 at risk EG00211 affected189 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA: 22.0	Systematic Assessment	EG0001 affected160 at risk EG0011 affected163 at risk EG0024 affected189 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0015 affected163 at risk EG0028 affected189 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA: 22.0	Systematic Assessment	EG0004 affected160 at risk EG0012 affected163 at risk EG00210 affected189 at risk EG003
Memory impairment	Nervous system disorders	MedDRA: 22.0	Systematic Assessment	EG0003 affected160 at risk EG0014 affected163 at risk EG00210 affected189 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

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

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring