Velcade,Thalidomide, and Dexamethasone Versus Velcade and... | NCT00507416

Label	Type	Description	Intervention Names
Bortezomib and Dexamethasone (VD)	Experimental	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).	Drug: Bortezomib Drug: Dexamethasone
Bortezomib, Thalidomide, and Dexamethasone (VTD)	Experimental	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance) .	Drug: Bortezomib Drug: Dexamethasone Drug: Thalidomide
Bortezomib, Melphalan and Prednisone (VMP)	Experimental	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).	Drug: Bortezomib Drug: Melphalan Drug: Prednisone

Name	Type	Description	Arm Group Labels	Other Names
Bortezomib	Drug	Bortezomib bolus intravenous (IV) injection	Bortezomib and Dexamethasone (VD) Bortezomib, Melphalan and Prednisone (VMP) Bortezomib, Thalidomide, and Dexamethasone (VTD)

Measure	Description	Time Frame
Progression Free Survival (PFS)	PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria. Progressive disease requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl) Urine M-component (absolute increase ≥ 200 mg/24 hours) In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl) Bone marrow plasma cell percentage (absolute % ≥ 10%) Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease	From randomization until disease progression. Median follow-up time was 43 months.

Measure	Description	Time Frame
Percentage of Participants With an Overall Response	Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria. CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h). PR requires 1 of the following: ≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%. If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required.

Name	Affiliation	Role
Medical Monitor	Millennium Pharmaceuticals, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Birmingham Hematology Oncology Assciates, LLC		Birmingham	Alabama	35205	United States
Desert Oasis Cancer Center

PubMed Identifier	Type	Citation	Retractions
26056177	Derived	Niesvizky R, Flinn IW, Rifkin R, Gabrail N, Charu V, Clowney B, Essell J, Gaffar Y, Warr T, Neuwirth R, Zhu Y, Elliott J, Esseltine DL, Niculescu L, Reeves J. Community-Based Phase IIIB Trial of Three UPFRONT Bortezomib-Based Myeloma Regimens. J Clin Oncol. 2015 Nov 20;33(33):3921-9. doi: 10.1200/JCO.2014.58.7618. Epub 2015 Jun 8.

ID	Title	Description
FG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS)

PFS is defined as the time from randomization to disease progression or death, whichever occurs first. Participants who did not progress and were still alive at the cut-off date were censored at the date of last contact. Response was assessed by the Investigator using the International Myeloma Working Group (IMWG) uniform response criteria.

Progressive disease requires 1 of the following:

Increase of ≥ 25% from nadir in:
- Serum M-component (absolute increase ≥ 0.5 g/dl)
- Urine M-component (absolute increase ≥ 200 mg/24 hours)
- In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)
- Bone marrow plasma cell percentage (absolute % ≥ 10%)
Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.
Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease

Intent-to-treat (all randomized participants)

Posted

Median

95% Confidence Interval

months

From randomization until disease progression. Median follow-up time was 43 months.

ID	Title	Description
OG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG001	Bortezomib, Thalidomide, and Dexamethasone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG002	Bortezomib, Melphalan and Prednisone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

Units	Counts
Participants	OG000168 OG001167 OG002167

Title

Denominators

Categories

Title	Measurements
	OG00014.7(12.0 to 18.6) OG00115.4(12.6 to 24.2) OG00217.3(14.8 to 20.3)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002		Wald test		0.458	The global difference among arms was based on the Wald test.												No	Superiority or Other

Secondary

Percentage of Participants With an Overall Response

Overall response defined as a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR), assessed by the Investigator using the IMWG uniform response criteria.

CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.

VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours (h).

PR requires 1 of the following:

≥50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to <200 mg/24 h, or
If M-protein not measurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels, or
If FLC not measurable, a ≥ 50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%.

If present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required.

Response-Evaluable population, defined as all participants who received at least 1 dose of any study drug, have measurable disease at baseline, and have at least one post-baseline M-protein measurement.

Posted

Number

percentage of participants

Response assessed every other cycle for up to 13 cycles (49 weeks).

ID	Title	Description
OG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

Secondary

Percentage of Participants With a Complete Response

Participants with a best overall response of complete response, defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Response was assessed by the Investigator using the IMWG uniform response criteria.

Posted

Number

percentage of participants

Response assessed every other cycle, for up to 13 cycles (49 weeks).

ID	Title	Description
OG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG001	Bortezomib, Thalidomide, and Dexamethasone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

Secondary

Percentage of Participants With a Complete Response or a Very Good Partial Response

Complete response is defined by negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow.

Very good partial response is defined by serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.

Response was assessed by the Investigator using the IMWG uniform response criteria.

Posted

Number

percentage of participants

Response assessed every other cycle for up to 13 cycles (49 weeks).

ID	Title	Description
OG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG001	Bortezomib, Thalidomide, and Dexamethasone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

Secondary

Duration of Response

Duration of response is defined in participants with an overall response as the time between first documentation of response and disease progression. Responders without disease progression were censored at the last clinical assessment of response.

Participants with an overall response

Posted

Median

95% Confidence Interval

months

From first documented response until disease progression. Median follow-up time was 43 months.

ID	Title	Description
OG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG001	Bortezomib, Thalidomide, and Dexamethasone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG002	Bortezomib, Melphalan and Prednisone

Secondary

Overall Survival

Overall survival is defined as the time between randomization and death. Participants still alive at the cutoff date or lost to follow-up were censored at the date of last contact.

Intent to treat

Posted

Median

95% Confidence Interval

months

From randomization until death. Median follow-up time was 43 months.

ID	Title	Description
OG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG001	Bortezomib, Thalidomide, and Dexamethasone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG002	Bortezomib, Melphalan and Prednisone

Secondary

Time to Alternative Therapy

Time to alternative therapy is defined as the time between randomization and alternative therapy. Participants who did not receive alternative therapy were censored at the time of last contact.

Intent to Treat

Posted

Median

95% Confidence Interval

months

From randomization until alternative therapy. Median follow-up time was 43 months.

ID	Title	Description
OG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG001	Bortezomib, Thalidomide, and Dexamethasone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG002	Bortezomib, Melphalan and Prednisone

Secondary

Change From Baseline in EORTC QLQ-C30 - Global Health Status

The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).

The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.

Intent-to-treat population with available data at each time point (indicated by "n").

Posted

Mean

Standard Deviation

units on a scale

Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13

ID	Title	Description
OG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
OG001	Bortezomib, Thalidomide, and Dexamethasone

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00018 affected165 at risk EG00112 affected158 at risk EG00210 affected163 at risk
Lobar pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Bronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Bacteraemia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Septic shock	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Bacterial sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Device related sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Urosepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Urinary tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0012 affected158 at risk EG0024 affected163 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Gastroenteritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Diverticulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Appendicitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Peritonitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Periorbital cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Herpes zoster	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0022 affected163 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Staphylococcal abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Bursitis infective	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Fungal skin infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Device related infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Viral infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00012 affected165 at risk EG0015 affected158 at risk EG0028 affected163 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0015 affected158 at risk EG0026 affected163 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0014 affected158 at risk EG0024 affected163 at risk
Constipation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected165 at risk EG0013 affected158 at risk EG0023 affected163 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected165 at risk EG0013 affected158 at risk EG0024 affected163 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0014 affected158 at risk EG0021 affected163 at risk
Ileus	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0023 affected163 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Colitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Duodenal perforation	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Gastritis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0008 affected165 at risk EG0016 affected158 at risk EG0029 affected163 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0011 affected158 at risk EG0024 affected163 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0013 affected158 at risk EG0021 affected163 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0015 affected158 at risk EG0024 affected163 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0013 affected158 at risk EG0020 affected163 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Neuralgic amyotrophy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Syncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected165 at risk EG0015 affected158 at risk EG0025 affected163 at risk
Lethargy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Spinal haematoma	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Encephalopathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Dizziness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Dizziness postural	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Dementia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Dementia with Lewy bodies	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Neuralgia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Sciatica	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Cognitive disorder	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Quadriplegia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Convulsion	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Spinal cord compression	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Asthenia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected165 at risk EG0013 affected158 at risk EG0023 affected163 at risk
Fatigue	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0014 affected158 at risk EG0022 affected163 at risk
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected165 at risk EG0012 affected158 at risk EG0022 affected163 at risk
Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Non-cardiac chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Oedema peripheral	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Generalised oedema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Death	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Multi-organ failure	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Chills	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Nodule	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected165 at risk EG0017 affected158 at risk EG0021 affected163 at risk
Atrial flutter	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected165 at risk EG0018 affected158 at risk EG0021 affected163 at risk
Angina pectoris	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Bradycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Arrhythmia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Cardiac arrest	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Pericardial effusion	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Right ventricular failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0013 affected158 at risk EG0026 affected163 at risk
Orthostatic hypotension	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected165 at risk EG0011 affected158 at risk EG0025 affected163 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0007 affected165 at risk EG0014 affected158 at risk EG0022 affected163 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Peripheral embolism	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Phlebitis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected165 at risk EG0014 affected158 at risk EG0022 affected163 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected165 at risk EG0014 affected158 at risk EG0021 affected163 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0013 affected158 at risk EG0020 affected163 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0013 affected158 at risk EG0025 affected163 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0012 affected158 at risk EG0022 affected163 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0022 affected163 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0013 affected158 at risk EG0023 affected163 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0015 affected158 at risk EG0021 affected163 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Fractured ischium	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Drug dispensing error	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected165 at risk EG0016 affected158 at risk EG0022 affected163 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0023 affected163 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0023 affected163 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Renal failure	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG0023 affected163 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0022 affected163 at risk
Renal impairment	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Urinary retention	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Haematuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
International normalised ratio increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Prothrombin time prolonged	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Alanine aminotransferase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hepatic enzyme increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Blood creatinine increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Klebsiella test positive	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Blood culture positive	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Blood potassium decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Haemoglobin decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Troponin I increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
White blood cell count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Confusional state	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Depression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Mental status changes	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Panic attack	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Acute psychosis	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Withdrawal syndrome	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Weight decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0004 affected165 at risk EG0012 affected158 at risk EG0026 affected163 at risk
Platelet count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0011 affected158 at risk EG0027 affected163 at risk
Blood sodium decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0013 affected158 at risk EG0023 affected163 at risk
Blood uric acid increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0013 affected158 at risk EG0023 affected163 at risk
Neutrophil count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0026 affected163 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0023 affected163 at risk
Blood urea increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Protein total increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Weight increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0013 affected158 at risk EG0020 affected163 at risk
Blood bilirubin increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Troponin T increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Blood calcium increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Blood chloride decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Blood creatinine decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Blood glucose increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Blood immunoglobulin G increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Blood phosphorus decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Blood potassium increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Breath sounds abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Carbon monoxide diffusing capacity decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Lymphocyte count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Lymphocyte count increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Red blood cell count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Dysgeusia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0014 affected158 at risk EG0022 affected163 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Tremor	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Balance disorder	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Paraesthesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0023 affected163 at risk
Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Somnolence	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Ageusia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Cranial nerve disorder	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Dysarthria	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Memory impairment	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Ataxia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Hemiparesis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hypogeusia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Polyneuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Presyncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0015 affected158 at risk EG0023 affected163 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0024 affected163 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0022 affected163 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Heat rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Lichenoid keratosis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Insomnia	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0009 affected165 at risk EG0016 affected158 at risk EG0026 affected163 at risk
Anxiety	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Mood altered	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Disorientation	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Mood swings	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Agitation	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Anhedonia	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Anxiety disorder due to a general medical condition	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Delusion	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Depressed mood	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Dysphoria	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Restlessness	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Oral candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0024 affected163 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Hordeolum	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Oral fungal infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Sinusitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Cystitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Folliculitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Furuncle	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Herpes zoster ophthalmic	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Localised infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Nasopharyngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Skin bacterial infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0015 affected158 at risk EG0023 affected163 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0018 affected158 at risk EG0024 affected163 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Gout	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0011 affected158 at risk EG00212 affected163 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0024 affected163 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Vision blurred	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0015 affected158 at risk EG0021 affected163 at risk
Conjunctivitis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Eye swelling	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Visual impairment	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Blepharitis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Conjunctivitis allergic	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Diplopia	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Eye haemorrhage	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Eye pruritus	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Lacrimation increased	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Ocular hyperaemia	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0013 affected158 at risk EG0020 affected163 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0021 affected163 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Ascites	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Flatulence	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Toothache	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0012 affected158 at risk EG0021 affected163 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0012 affected158 at risk EG0020 affected163 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Gait disturbance	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Catheter site erythema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Drug withdrawal syndrome	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Face oedema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Feeling jittery	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Influenza like illness	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Irritability	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Malaise	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Oedema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Soft tissue inflammation	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Hypertension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0013 affected158 at risk EG0022 affected163 at risk
Hot flush	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Haematoma	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Withdrawal hypertension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Dysuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0010 affected158 at risk EG0023 affected163 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0022 affected163 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Azotaemia	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Nocturia	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Pericarditis	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Restrictive cardiomyopathy	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected165 at risk EG0010 affected158 at risk EG0020 affected163 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cushingoid	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk
Seasonal allergy	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0011 affected158 at risk EG0020 affected163 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 affected165 at risk EG0010 affected158 at risk EG0021 affected163 at risk

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D001896	Boron Compounds
D009930	Organic Chemicals
D011719	Pyrazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D010649	Phenylalanine
D024322	Amino Acids, Aromatic
D000598	Amino Acids, Cyclic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D011244	Pregnadienediols
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D010881	Piperidones
D010880	Piperidines
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
BG001	Bortezomib, Thalidomide, and Dexamethasone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
BG002	Bortezomib, Melphalan and Prednisone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bortezomib and Dexamethasone	Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).	88	165	57	165
EG001	Bortezomib, Thalidomide, and Dexamethasone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).	92	158	68	158
EG002	Bortezomib, Melphalan and Prednisone	Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).	83	163	68	163

ID	Term
D000069286	Bortezomib
D003907	Dexamethasone
D008558	Melphalan
D011241	Prednisone
D013792	Thalidomide