An Observational Study of Presentation, Treatment Pattern... | NCT02761187

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Newly Diagnosed Multiple Myeloma		Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).	Other: No Intervention
Relapsed/Refractory Multiple Myeloma		Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	As this was an observational study, no intervention was administered.	Newly Diagnosed Multiple Myeloma Relapsed/Refractory Multiple Myeloma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Co-morbidities	Charlson Comorbidity Index (CCI) was used to represent number of participants with co-morbidities. CCI is a method of categorizing comorbidities of participants. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a participant. A score of 0 = no comorbidities found, 1 = not ill, 2 = mildly ill, 3 = moderately ill, 4 = severely ill, and ≥5 = moribund. The higher the score, the more likely the predicted outcome resulted in mortality or higher resource use.	Baseline up to 5 years
Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)	Participants diagnosed with NDMM and R/RMM were determined at the start of the study.	At Baseline
Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study		Baseline up to 5 years
Sites of Disease Diagnosed With ND MM and R/R MM		Baseline up to 5 years
Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status	ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 6 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The line of Therapy was determined at study entry.

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Receiving Different Treatment Combinations		Baseline up to 5 years
Number of Treatment Sequencing	Drug classes were based on the earliest regimen in each corresponding Line of Therapy. The data for this outcome measure was analyzed as per line of therapy.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
CARTI Cancer Center		Little Rock	Arkansas	72205	United States
University of Arkansas For Medical Sciences

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41528195	Derived	Puig N, Leleu X, Lee HC, Davies FE, Hajek R, Hungria V, Thompson MA, Cook G, Ojeda JV, Weisel KC, Berdeja JG, Usmani SZ, Symeonidis A, Nascimento-Ferreira I, Arthur D, Mokra L, Ren K, Cherepanov D, Terpos E. Comparative Effectiveness and Safety of PI-Rd Triplets in Relapsed/Refractory Multiple Myeloma: INSIGHT-MM Data Analysis. Eur J Haematol. 2026 Apr;116(4):458-470. doi: 10.1111/ejh.70079. Epub 2026 Jan 13.
37807952

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Newly Diagnosed (ND) MM	Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
FG001	Relapsed/Refractory (R/R) MM

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	Apr 11, 2018	Sep 30, 2022

Arm/Group Information

ID	Title	Description
BG000	NDMM	Participants with newly diagnosed MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
BG001	RRMM	Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
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

Age at study entry was provided by the participant or calculated from date of birth if age was missing as the integer part of: Age (years) = (Informed Consent Date - Date of Birth + 1) / 365.25.

Number analyzed are the number of participants available for baseline age continuous.

Mean

Standard Deviation

years

Title

Denominators

Categories

0-1

Title	Measurements
	OG0001279 OG0011064

2-3

Title	Measurements
	OG000

Primary

Number of Participants Diagnosed With Newly Diagnosed Multiple Myeloma (NDMM) and Relapsed/Refractory Multiple Myeloma (R/RMM)

Participants diagnosed with NDMM and R/RMM were determined at the start of the study.

All Enrolled Population included all participants who signed the inform consent form.

Posted

Count of Participants

Participants

At Baseline

ID	Title	Description
OG000	NDMM	Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
OG001	RRMM	Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Units	Counts
Participants	OG000

Primary

Number of Participants Diagnosed With Symptoms of ND MM and R/R MM During the Study

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	NDMM	Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
OG001	RRMM	Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Units	Counts
Participants	OG000

Primary

Sites of Disease Diagnosed With ND MM and R/R MM

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	NDMM	Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
OG001	RRMM	Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Units	Counts
Participants	OG000

Primary

Number of Participants With ECOG (Eastern Cooperative Oncology Group) Performance Status

ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 6 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. The line of Therapy was determined at study entry.

All Enrolled Population included all participants who signed informed consent. Overall number of participants analyzed is the number of participants available for analysis.

Posted

Count of Participants

Participants

At Baseline

ID	Title	Description
OG000	NDMM	Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
OG001	RRMM	Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Primary

Number of Participants With Myeloma Frailty Index

Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness. The Myeloma Frailty Index is a composite index that was calculated using the points system, which produces a range of values from 0 to 5. Participants with score 0= fit, score 1= intermediate, and score ≥2= frail. Higher score indicates likeliness that the predicted outcome will result in frailty. The line of Therapy was determined at study entry.

All Enrolled Population included all participants who signed the inform consent form. Overall number of participants analyzed is the number of participants available for analysis.

Posted

Count of Participants

Participants

At Baseline

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Primary

Number of Participants Evaluated for Minimal Residual Disease (MRD)

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	NDMM	Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
OG001	RRMM	Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Units	Counts
Participants	OG000

Primary

Number of Participants Evaluated for Gene Expression Profiling (GEP)

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	NDMM	Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
OG001	RRMM	Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Units	Counts
Participants	OG000

Primary

Number of Participants Evaluated for Cytogenetics Using Fluorescence in Situ Hybridization (FISH)

FISH methodology was reported with Yes/No results for the following tests: deletion (17p)/p53 [Del(17p)/p53], translocation (4,14) [t(4,14)], and translocation (14,16) [t(14,16)].

All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.

Posted

Count of Participants

Participants

At Baseline

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002

Primary

Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage

ISS disease stages were defined as I:low risk, β2-Microglobulin<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. <=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. >300 U/L).

All Enrolled Population included all participants who signed informed consent. Overall number of participants are the number of participants available for analysis.

Posted

Count of Participants

Participants

At Baseline

ID	Title	Description
OG000	NDMM	Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
OG001	RRMM	Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

Primary

Duration of Treatment for Participants With and Without Stem Cell Transplant

Data was analyzed for participants with and without stem cell transplant for all enrolled population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data.

All Enrolled Population included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. Overall number analyzed are the number of participants with data available for analyses. The data is reported as per the known line of therapies.

Posted

Median

Full Range

months

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Primary

Overall Survival (OS)

Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis.

All Enrolled Population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.

Posted

Median

95% Confidence Interval

months

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002

Primary

Disease Progression Status on Each Regimen

Disease progression status was assessed by physician interpretation of IMWG Response criteria.

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Primary

Response to Each Regimen

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG003

Primary

Time to Next Therapy

The line of Therapy was determined at study entry. The Kaplan Meier estimates was used for the analysis.

Posted

Median

95% Confidence Interval

months

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy

Primary

Number of Participants With Stem Cell Transplant

Posted

Count of Participants

Participants

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Secondary

Number of Participants Receiving Different Treatment Combinations

All Enrolled Population included all participants who signed the inform consent form. Participants were reported more than once in each line of therapy. Data is reported only for 1st, 2nd 3rd and 4th line of therapy. The overall number of participants analyzed is the number of participants available for analyses.

Posted

Count of Participants

Participants

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Secondary

Number of Treatment Sequencing

Drug classes were based on the earliest regimen in each corresponding Line of Therapy. The data for this outcome measure was analyzed as per line of therapy.

All Enrolled Population included all participants who signed informed consent. Participants were reported more than once in each line of therapy. Data is reported only for 1st, 2nd and 3rd line of therapy.

Posted

Count of Participants

Participants

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Secondary

Number of Participants in the Treatment Rechallenge

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG003

Secondary

Number of Clinical Outcomes for Different Strategies

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG003

Secondary

Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Secondary

Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Secondary

Reasons for Treatment Modifications

All Enrolled Population included all participants who signed informed consent. Participants received more than one LOT and are counted in more than one LOT. The data is reported as per the known line of therapies. Participants were counted multiple times in different categories. The overall number of participants analyzed is the number of participants available for analyses.

Posted

Count of Participants

Participants

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Primary

Number of Participants With Global Health Status Scale/Quality of Life (QoL) Among MM Participants

The Global Health Status scale/QoL scale included 2 questions measured with a 7-point numeric rating scale (very poor to excellent). Raw scores are converted into scale scores ranging from 0 to 100. A higher score represents better HRQoL.

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

Secondary

Healthcare Resource Utilization (HRU) Among MM Participants

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG003

Secondary

Associations Between Presentation and Disease Characteristics

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG003

Secondary

Associations Between Choice Of Therapy and Clinical Outcomes

As the study was early terminated data was not collected for this outcome measure.

Posted

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG003

Secondary

Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.

Participants who received Takeda products and signed informed consent form were included in the analysis. As pre-specified in SAP, data for treatment-emergent adverse events was planned to be collected and reported for Takeda products only. Participants were counted more than once in each line of therapy towards the total. The data is reported as per the known line of therapies.

Posted

Count of Participants

Participants

Baseline up to 5 years

ID	Title	Description
OG000	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
OG001

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	1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).	351	1,790	269	1,849	306	1,849
EG001	2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).	418	1,331	101	773	125	773
EG002	3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).	420	1,050	82	455	79	455
EG003	4th Line of Therapy	The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).	348	739	43	239	39	239
EG004	>4th Line of Therapy	The most common treatment regimens prescribed in participants treated in >4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).	234	453	38	181	32	181
EG005	Robustness Concerns: 1st Line of Therapy	The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 1st line of therapy with concerns around the robustness of data were included in this arm.	58	340	0	0	0	0
EG006	Robustness Concerns: 2nd Line of Therapy	The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 2nd line of therapy with concerns around the robustness of data were included in this arm.	72	303	0	0	0	0
EG007	Robustness Concerns: 3rd Line of Therapy	The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 3rd line of therapy with concerns around the robustness of data were included in this arm.	65	222	0	0	0	0
EG008	Robustness Concerns: 4th Line of Therapy	The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in 4th line of therapy with concerns around the robustness of data were included in this arm.	32	86	0	0	0	0
EG009	Robustness Concerns: >4th Line of Therapy	The most common treatment regimens prescribed in participants treated in >4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years). Only participants treated in >4th line of therapy with concerns around the robustness of data were included in this arm.	6	24	0	0	0	0
EG010	Robustness Concerns: Unknown Line of Therapy	The 'Unknown Line of Therapy' indicates either: 1) participant was on a regimen on or after study entry, but missing line of therapy with respect to that regimen or 2) have not observed any regimen with line of therapy on or after study entry. Only participants in unknown line of therapy with concerns around the robustness of data were included in this arm.	28	147	0	0	0	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG0032 affected239 at risk EG0043 affected181 at risk EG0050 affected0 at risk EG0060 affected0 at risk EG0070 affected0 at risk EG0080 affected0 at risk EG0090 affected0 at risk EG0100 affected0 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Haematotoxicity	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0012 affected773 at risk EG0024 affected455 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0007 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Bradycardia	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0013 affected773 at risk EG0020 affected455 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0009 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Cardiac flutter	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Coronary artery thrombosis	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Microvascular coronary artery disease	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Pericarditis	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Restrictive cardiomyopathy	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Systolic dysfunction	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Parathyroid disorder	Endocrine disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0008 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pancreatic duct obstruction	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Asthenia	General disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Chest pain	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Death	General disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Disease progression	General disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Fatigue	General disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
General physical health deterioration	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0012 affected773 at risk EG0023 affected455 at risk EG003
Generalised oedema	General disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hyperthermia	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Influenza like illness	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Malaise	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Oedema peripheral	General disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pain	General disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pyrexia	General disorders	MedDRA20.0	Systematic Assessment	EG00010 affected1,849 at risk EG0013 affected773 at risk EG0024 affected455 at risk EG003
Biliary obstruction	Hepatobiliary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Gallbladder volvulus	Hepatobiliary disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Cytokine release syndrome	Immune system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Abscess limb	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Bronchitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Bursitis infective	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
COVID-19	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0012 affected773 at risk EG0022 affected455 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Cellulitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Cellulitis of male external genital organ	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Device related infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Diverticulitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Ear infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Endocarditis bacterial	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Enterococcal sepsis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Febrile infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Groin abscess	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Herpes zoster	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Influenza	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0022 affected455 at risk EG003
Intestinal sepsis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Kidney infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Klebsiella infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0010 affected773 at risk EG0028 affected455 at risk EG003
Meningitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Meningoencephalitis herpetic	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Metapneumovirus infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Parotitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pneumonia	Infections and infestations	MedDRA20.0	Systematic Assessment	EG00042 affected1,849 at risk EG00117 affected773 at risk EG00217 affected455 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Pneumonia parainfluenzae viral	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0015 affected773 at risk EG0022 affected455 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Rhinitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Sepsis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0008 affected1,849 at risk EG0014 affected773 at risk EG0023 affected455 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Septic shock	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Streptococcal sepsis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Systemic candida	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Urosepsis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Osteochondral fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Post procedural fever	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Postoperative respiratory distress	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Blood creatinine increased	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Cardiac murmur	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Ejection fraction decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Human metapneumovirus test positive	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Influenza A virus test positive	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Liver function test increased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Platelet count decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Respirovirus test positive	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Rotavirus test positive	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Rubulavirus test positive	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Troponin increased	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
White blood cell count decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Chest wall haematoma	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Lung adenocarcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Plasma cell leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0012 affected773 at risk EG0024 affected455 at risk EG003
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Spindle cell sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Autonomic neuropathy	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Balance disorder	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0014 affected773 at risk EG0021 affected455 at risk EG003
Dizziness	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Dysarthria	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Embolic cerebral infarction	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Headache	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Nervous system disorder	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Paralysis	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Post stroke seizure	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Seizure	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Somnolence	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Syncope	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Unresponsive to stimuli	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Device loosening	Product Issues	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Acute psychosis	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Confusional state	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Delirium	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG00010 affected1,849 at risk EG0013 affected773 at risk EG0024 affected455 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0014 affected773 at risk EG0021 affected455 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pulmonary microemboli	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Toe amputation	Surgical and medical procedures	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Embolism	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected0 at risk EG0020 affected455 at risk EG003
Hypotension	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Subclavian vein thrombosis	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0012 affected773 at risk EG0025 affected455 at risk EG0032 affected239 at risk EG0043 affected181 at risk EG0050 affected0 at risk EG0060 affected0 at risk EG0070 affected0 at risk EG0080 affected0 at risk EG0090 affected0 at risk EG0100 affected0 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cytopenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Haematotoxicity	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG00016 affected1,849 at risk EG0013 affected773 at risk EG0023 affected455 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA20.0	Systematic Assessment	EG00012 affected1,849 at risk EG00114 affected773 at risk EG00214 affected455 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Bradycardia	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Diastolic dysfunction	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Palpitations	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Systolic dysfunction	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Tachycardia	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Deafness unilateral	Ear and labyrinth disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Blepharitis	Eye disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Dacryoadenitis acquired	Eye disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Eyelid oedema	Eye disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hypermetropia	Eye disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Myopia	Eye disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Periorbital oedema	Eye disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Retinal disorder	Eye disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Vision blurred	Eye disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Aerophagia	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Anal dilatation	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG00013 affected1,849 at risk EG0017 affected773 at risk EG0021 affected455 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG00024 affected1,849 at risk EG00114 affected773 at risk EG00213 affected455 at risk EG003
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0013 affected773 at risk EG0027 affected455 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Asthenia	General disorders	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0014 affected773 at risk EG0020 affected455 at risk EG003
Chest pain	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Discomfort	General disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Fatigue	General disorders	MedDRA20.0	Systematic Assessment	EG00025 affected1,849 at risk EG00110 affected773 at risk EG0028 affected455 at risk EG003
General physical health deterioration	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Hyperpyrexia	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Influenza like illness	General disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Injection site pruritus	General disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Injection site rash	General disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Injection site reaction	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Malaise	General disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Oedema peripheral	General disorders	MedDRA20.0	Systematic Assessment	EG00011 affected1,849 at risk EG0014 affected773 at risk EG0024 affected455 at risk EG003
Peripheral swelling	General disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pyrexia	General disorders	MedDRA20.0	Systematic Assessment	EG0008 affected1,849 at risk EG0010 affected773 at risk EG0023 affected455 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Immunosuppression	Immune system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Oral allergy syndrome	Immune system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Bronchitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0013 affected773 at risk EG0020 affected455 at risk EG003
Candida sepsis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Catheter site infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cystitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Diverticulitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Eyelid infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Groin infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Herpes zoster	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Influenza	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Klebsiella infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Lymph gland infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Oral infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pharyngitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pneumonia	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0016 affected773 at risk EG0023 affected455 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pustule	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0013 affected773 at risk EG0020 affected455 at risk EG003
Sinusitis	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Tinea versicolour	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Tongue fungal infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Tooth abscess	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0008 affected1,849 at risk EG0013 affected773 at risk EG0023 affected455 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0013 affected773 at risk EG0021 affected455 at risk EG003
Viral infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Adenovirus test positive	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Blood creatinine increased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Blood glucose increased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Haemoglobin decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hepatitis E virus test positive	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Neutrophil count decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0005 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Platelet count decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0013 affected773 at risk EG0022 affected455 at risk EG003
Transaminases increased	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Weight decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Weight increased	Investigations	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
White blood cell count decreased	Investigations	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0023 affected455 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0013 affected773 at risk EG0021 affected455 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0022 affected455 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Steroid diabetes	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0009 affected1,849 at risk EG0013 affected773 at risk EG0021 affected455 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0013 affected773 at risk EG0022 affected455 at risk EG003
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Autonomic neuropathy	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Balance disorder	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Burning sensation	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Dizziness	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0008 affected1,849 at risk EG0013 affected773 at risk EG0022 affected455 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Dysarthria	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Formication	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Headache	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Lumbosacral radiculopathy	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Neuralgia	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG00064 affected1,849 at risk EG00131 affected773 at risk EG00215 affected455 at risk EG003
Neurotoxicity	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0013 affected773 at risk EG0020 affected455 at risk EG003
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG00043 affected1,849 at risk EG0019 affected773 at risk EG0023 affected455 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0012 affected773 at risk EG0020 affected455 at risk EG003
Somnolence	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Syncope	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Tremor	Nervous system disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Affect lability	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Agitation	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Anxiety	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Depression	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Insomnia	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0013 affected773 at risk EG0020 affected455 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Mood altered	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Mood swings	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Nervousness	Psychiatric disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Cystitis noninfective	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Urethral obstruction	Renal and urinary disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Penile erythema	Reproductive system and breast disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Testicular pain	Reproductive system and breast disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0006 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0012 affected773 at risk EG0022 affected455 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0012 affected773 at risk EG0021 affected455 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0021 affected455 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Dermatitis exfoliative generalised	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG00010 affected1,849 at risk EG0010 affected773 at risk EG0022 affected455 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0012 affected773 at risk EG0022 affected455 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0007 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rash maculovesicular	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0004 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Hypertension	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Hypotension	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0003 affected1,849 at risk EG0012 affected773 at risk EG0022 affected455 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Vasculitis	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0000 affected1,849 at risk EG0010 affected773 at risk EG0021 affected455 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG00010 affected1,849 at risk EG0011 affected773 at risk EG0020 affected455 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0002 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA20.0	Systematic Assessment	EG0001 affected1,849 at risk EG0010 affected773 at risk EG0020 affected455 at risk EG003

Certain Agreements

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