A Study to Evaluate Dara-CyBorD in Previously Untreated a... | NCT02951819

ID	Type	Description	Link
54767414MMY2012	Other Identifier	Janssen Scientific Affairs, LLC

Label	Type	Description	Intervention Names
Dara-CyBorD	Experimental	Subjects will receive Daratumumab along with Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) as induction on a 28-day cycle length and Daratumab and Dexamethasone on Day 1 of each cycle for 12 cycles as maintenance therapy.	Drug: Daratumumab Drug: Cyclophosphamide Drug: Bortezomib Drug: Dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
Daratumumab	Drug	For induction therapy cycle 1 day 1 and day 2 doses of daratumumab will be 8 milligram/kilogram (mg/kg). Starting cycle 1 week 2 until the completion of week 8 of daratumumab patients will receive 16 mg/kg Intravenously (IV) weekly. Starting week 9 until the completion of week 24 therapy daratumumab will be administered every other week at 16 mg/kg IV. Starting week 25 and beyond for induction therapy daratumumab will be given once every 4 weeks.

Measure	Description	Time Frame
Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR)	Percentage of participants who achieved CR or VGPR (as per International Myeloma Working Group [IMWG] criteria) was reported. CR: negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percent (%) plasma cells (PC) in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90% reduction in serum M-protein plus urine M-protein level < 100 milligram per 24 hours (mg/24hours).	After 4 cycles of Induction (Approximately 4 months)

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR: percentage of participants achieved PR or better (PR,VGPR,CR,sCR) per IMWG. CR:negative immunofixation on serum, urine, disappearance of soft tissue plasmacytomas,<5% PCs in bone marrow(BM). sCR:CR plus normal FLC ratio,absence of clonal cells in BM by immunohistochemistry, immunofluorescence. VGPR:Serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24hours. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200mg/24hours. If serum, urine M-protein unmeasurable, a>=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum, urine M-protein not measurable, serum free light assay is not measurable,>=50% reduction in PCs required in place of M-protein,provided baseline bone marrow PCs% >=30%, if present at baseline, a >=50% reduction in size of soft tissue plasmacytomas is also required.

Name	Affiliation	Role
Janssen Scientific Affairs, LLC Clinical Trial	Janssen Scientific Affairs, LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
35730586	Derived	Yimer H, Melear J, Faber E, Bensinger WI, Burke JM, Narang M, Stevens D, Gray KS, Lutska Y, Bobba P, Qi K, Hoehn D, Qi M, Lin TS, Rifkin RM. Daratumumab, cyclophosphamide, bortezomib, and dexamethasone for multiple myeloma: final results of the LYRA study. Leuk Lymphoma. 2022 Oct;63(10):2383-2392. doi: 10.1080/10428194.2022.2076847. Epub 2022 Jun 22.

ID	Title	Description
FG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 2, 2017	Mar 8, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR)

Percentage of participants who achieved CR or VGPR (as per International Myeloma Working Group [IMWG] criteria) was reported. CR: negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percent (%) plasma cells (PC) in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90% reduction in serum M-protein plus urine M-protein level < 100 milligram per 24 hours (mg/24hours).

Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.

Posted

Number

95% Confidence Interval

Percentage of Participants

After 4 cycles of Induction (Approximately 4 months)

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
OG001	Relapsed Multiple Myeloma (RMM)	Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Units	Counts
Participants	OG00086 OG00114

Title

Denominators

Categories

Title	Measurements
	OG00044.2(33.5 to 55.3) OG00157.1(28.9 to 82.3)

Secondary

Overall Response Rate (ORR)

ORR: percentage of participants achieved PR or better (PR,VGPR,CR,sCR) per IMWG. CR:negative immunofixation on serum, urine, disappearance of soft tissue plasmacytomas,<5% PCs in bone marrow(BM). sCR:CR plus normal FLC ratio,absence of clonal cells in BM by immunohistochemistry, immunofluorescence. VGPR:Serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24hours. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200mg/24hours. If serum, urine M-protein unmeasurable, a>=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum, urine M-protein not measurable, serum free light assay is not measurable,>=50% reduction in PCs required in place of M-protein,provided baseline bone marrow PCs% >=30%, if present at baseline, a >=50% reduction in size of soft tissue plasmacytomas is also required.

Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

After 4 Cycles of Induction (4 months), at End of Induction (4 to 8 months) and at the End of Maintenance (12 months)

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Secondary

Time to Very Good Partial Response (VGPR) or Better

Time to VGPR or Better response was defined as duration from the date of first dose (start of induction) to the date of initial documentation of the response (VGPR or better) which was confirmed by a repeated measurement as required by the IMWG criteria. VGPR is defined by IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90 % reduction in serum M-protein plus urine M-protein level < 100 milligram/24 hours (mg/24 hours).

Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.

Posted

Median

95% Confidence Interval

Months

Up to 36 months

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Secondary

Time to Partial Response (PR) or Better

Time to PR or Better response was defined as duration from the date of first dose (start of induction) to the date of initial documentation of the response (PR or better) which was confirmed by a repeated measurement as required by the IMWG criteria. PR is defined as per IMWG criteria as >= 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >= 90% or to < 200 mg/24hours. If the serum and urine M-protein are unmeasurable, a>= 50% decrease in the difference between involved and uninvolved Free light chain (FLC) levels is required in the place of the M-protein criteria. If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cells percentage was >=30%. In addition to the above listed criteria, if present at baseline, a >= 50% reduction in the size of soft tissue plasmacytomas is also required.

Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.

Posted

Median

95% Confidence Interval

Months

Up to 12 months

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Secondary

Duration of Response (DOR)

DOR was defined for participants with a confirmed response (PR or better) as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria or death due to progressive disease. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200 mg/24hours. If serum and urine M-protein are unmeasurable, a >=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in PCs is required in place of M-protein, provided baseline bone marrow PCs % was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

Population included responders (PR or better) in response-evaluable set.

Posted

Median

95% Confidence Interval

Months

Up to 36 months

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Secondary

Progression Free Survival (PFS)

PFS: duration from date of first dose (start of induction) to date of first documented evidence of progressive disease (PD) based on computerized algorithm per IMWG criteria or death due to any cause, whichever occurred first. PD: 25% increase from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 g/dL and >=200 mg/24 hours respectively);Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase>10 mg/dL);Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow PC% (absolute % >=10%); Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

Full analysis set is defined as enrolled participants who provided informed consent and met eligibility criteria.

Posted

Median

95% Confidence Interval

Months

Up to 36 months

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Secondary

Time to Disease Progression (TTP)

TTP was defined as the time between the date of first dose (start of induction) and the date of first documented evidence of confirmed PD, as defined in the IMWG response criteria. PD per IMWG criteria: Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 g/deciliter (dL) and >=200 mg/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase>10 mg/dL); Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow PC% (absolute % >=10%); Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.

Full Analysis Set defined as enrolled subjects who provided informed consent and met eligibility criteria.

Posted

Median

95% Confidence Interval

Months

Approximately 15 months

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Secondary

Overall Survival (OS)

Overall survival (OS) was measured from the date of first dose (start of induction) to the date of death due to any cause.

Full analysis set is defined as enrolled participants who provided informed consent and met eligibility criteria.

Posted

Median

95% Confidence Interval

Months

Up to 36 months

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
OG001	Relapsed Multiple Myeloma (RMM)	Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Secondary

Percentage of Participants With Treatment Emergent-Adverse Event

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and approximately up to 36 months that were absent before treatment or that worsened relative to pre-treatment state.

Safety Analysis Set defined as enrolled participants who received at least 1 dose (partial or complete) of study treatment (Dara-CyBorD).

Posted

Number

Percentage of participants

Up to 36 months

ID	Title	Description
OG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Fatigue	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Pyrexia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bacteraemia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bacterial Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bronchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Cellulitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Diverticulitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Herpes Zoster Disseminated	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Influenza	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Otitis Externa	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0012 affected14 at risk
Pneumonia Parainfluenzae Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pneumonia Streptococcal	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bone Lesion	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Acute Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Syncope	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Mental Status Changes	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Nephrotic Syndrome	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Laryngeal Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hypotension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected86 at risk EG0011 affected14 at risk
Hyperleukocytosis	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Increased Tendency to Bruise	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0012 affected14 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected86 at risk EG0013 affected14 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0012 affected14 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bradycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Palpitations	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Pericardial Effusion	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Deafness	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Deafness Bilateral	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Ear Congestion	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Ear Discomfort	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Eustachian Tube Obstruction	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Excessive Cerumen Production	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Middle Ear Inflammation	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hypothyroidism	Endocrine disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Cataract	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Cataract Subcapsular	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Chalazion	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Diplopia	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dry Eye	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Eye Discharge	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Eye Irritation	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Eye Pruritus	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Eye Swelling	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Lacrimation Increased	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0012 affected14 at risk
Ocular Hyperaemia	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Periorbital Oedema	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Photophobia	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Retinal Haemorrhage	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Swelling of Eyelid	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Vision Blurred	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0012 affected14 at risk
Visual Impairment	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Vitreous Floaters	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0011 affected14 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0014 affected14 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0010 affected14 at risk
Anal Incontinence	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Aphthous Ulcer	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00027 affected86 at risk EG0010 affected14 at risk
Dental Caries	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dental Discomfort	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00038 affected86 at risk EG0016 affected14 at risk
Diverticulum	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0011 affected14 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected86 at risk EG0012 affected14 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Enteritis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Faeces Discoloured	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Flatulence	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0012 affected14 at risk
Gingival Disorder	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Haematochezia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Hyperaesthesia Teeth	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Incarcerated Inguinal Hernia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Irritable Bowel Syndrome	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Mouth Ulceration	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00043 affected86 at risk EG0013 affected14 at risk
Oesophageal Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Oral Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Retching	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Swollen Tongue	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Toothache	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0010 affected14 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00025 affected86 at risk EG0015 affected14 at risk
Vomiting Projectile	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Asthenia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0011 affected14 at risk
Axillary Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Catheter Site Bruise	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Catheter Site Erythema	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Catheter Site Haemorrhage	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Catheter Site Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Catheter Site Pruritus	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Chest Discomfort	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0012 affected14 at risk
Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Chills	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected86 at risk EG0011 affected14 at risk
Face Oedema	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Fatigue	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00058 affected86 at risk EG0017 affected14 at risk
Feeling Cold	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Feeling Hot	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Feeling Jittery	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Gait Disturbance	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Influenza Like Illness	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Infusion Site Extravasation	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Injection Site Erythema	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0011 affected14 at risk
Injection Site Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Injection Site Rash	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Injection Site Reaction	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Localised Oedema	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Malaise	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Medical Device Discomfort	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Oedema	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Oedema Peripheral	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00021 affected86 at risk EG0011 affected14 at risk
Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0012 affected14 at risk
Peripheral Swelling	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0012 affected14 at risk
Pyrexia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected86 at risk EG0011 affected14 at risk
Tenderness	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Thirst	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Xerosis	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Hypersensitivity	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Seasonal Allergy	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0010 affected14 at risk
Acute Sinusitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Arthritis Infective	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bronchiolitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Bronchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected86 at risk EG0011 affected14 at risk
Bronchitis Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Candida Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Cellulitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Conjunctivitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0010 affected14 at risk
Cytomegalovirus Chorioretinitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Device Related Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Diverticulitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Ear Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Eye Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Folliculitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Fungal Skin Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Gingival Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Herpes Zoster Disseminated	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Hordeolum	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected86 at risk EG0010 affected14 at risk
Infected Bite	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Influenza	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0010 affected14 at risk
Localised Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected86 at risk EG0015 affected14 at risk
Oral Candidiasis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Oral Herpes	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Otitis Media	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Pharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0013 affected14 at risk
Pseudomonal Bacteraemia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Rash Pustular	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Rhinitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Sinusitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected86 at risk EG0014 affected14 at risk
Skin Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Tinea Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Tooth Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00030 affected86 at risk EG0017 affected14 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected86 at risk EG0010 affected14 at risk
Viral Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Wound Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Abdominal Wall Wound	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Bone Contusion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bone Fragmentation	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Cartilage Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0011 affected14 at risk
Eye Contusion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Eyelid Contusion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected86 at risk EG0011 affected14 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Radiation Skin Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0010 affected14 at risk
Aspartate Aminotransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0010 affected14 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0011 affected14 at risk
Blood Pressure Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Breath Sounds Abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Oxygen Saturation Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Prostatic Specific Antigen Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Weight Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected86 at risk EG0010 affected14 at risk
Weight Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0010 affected14 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00018 affected86 at risk EG0012 affected14 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00015 affected86 at risk EG0012 affected14 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Fluid Retention	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected86 at risk EG0010 affected14 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0012 affected14 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00019 affected86 at risk EG0011 affected14 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected86 at risk EG0012 affected14 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0010 affected14 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Increased Appetite	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Vitamin B12 Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00021 affected86 at risk EG0013 affected14 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00027 affected86 at risk EG0016 affected14 at risk
Bone Lesion	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected86 at risk EG0012 affected14 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Extremity Contracture	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Jaw Disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Joint Range of Motion Decreased	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0011 affected14 at risk
Limb Discomfort	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0011 affected14 at risk
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Muscle Twitching	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected86 at risk EG0010 affected14 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected86 at risk EG0013 affected14 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected86 at risk EG0013 affected14 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0014 affected14 at risk
Myalgia Intercostal	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0011 affected14 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0011 affected14 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00015 affected86 at risk EG0014 affected14 at risk
Pain in Jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0012 affected14 at risk
Bowen's Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Squamous Cell Carcinoma of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Urethral Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Anosmia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Burning Sensation	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Cognitive Disorder	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dizziness	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00016 affected86 at risk EG0011 affected14 at risk
Dizziness Postural	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dysarthria	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected86 at risk EG0012 affected14 at risk
Headache	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00024 affected86 at risk EG0013 affected14 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Lethargy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Memory Impairment	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Mental Impairment	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Muscle Spasticity	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Neuralgia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00014 affected86 at risk EG0012 affected14 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0013 affected14 at risk
Peripheral Motor Neuropathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00020 affected86 at risk EG0013 affected14 at risk
Peroneal Nerve Palsy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Seizure	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Sinus Headache	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Somnolence	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Syncope	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Taste Disorder	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Tremor	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Vith Nerve Disorder	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Device Malfunction	Product Issues	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Agitation	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Anxiety	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected86 at risk EG0010 affected14 at risk
Confusional State	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Depression	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected86 at risk EG0011 affected14 at risk
Emotional Disorder	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Insomnia	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00028 affected86 at risk EG0012 affected14 at risk
Irritability	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Mental Status Changes	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Nightmare	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Personality Change	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Restlessness	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Bladder Discomfort	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bladder Outlet Obstruction	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bladder Spasm	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dysuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0011 affected14 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Micturition Urgency	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Nephrotic Syndrome	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Nocturia	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0012 affected14 at risk
Pollakiuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0011 affected14 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Urinary Hesitation	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Urinary Retention	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Urine Flow Decreased	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Urogenital Fistula	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Breast Calcifications	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Breast Pain	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Female Genital Tract Fistula	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Genital Erythema	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Nipple Pain	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Vulvovaginal Dryness	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Vulvovaginal Pruritus	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00042 affected86 at risk EG0016 affected14 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00027 affected86 at risk EG0013 affected14 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0011 affected14 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0012 affected14 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Laryngeal Inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected86 at risk EG0013 affected14 at risk
Nasal Dryness	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected86 at risk EG0014 affected14 at risk
Paranasal Sinus Discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Paranasal Sinus Hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0014 affected14 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Respiratory Symptom	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0012 affected14 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected86 at risk EG0010 affected14 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0012 affected14 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0012 affected14 at risk
Sinus Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Sinus Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0012 affected14 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0011 affected14 at risk
Throat Tightness	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Upper Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0011 affected14 at risk
Actinic Keratosis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0011 affected14 at risk
Chronic Pigmented Purpura	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Cold Sweat	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dermal Cyst	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0011 affected14 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0011 affected14 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected86 at risk EG0011 affected14 at risk
Nail Disorder	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected86 at risk EG0011 affected14 at risk
Nail Pigmentation	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Pain of Skin	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00020 affected86 at risk EG0011 affected14 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected86 at risk EG0011 affected14 at risk
Rash Follicular	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Rash Macular	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Skin Disorder	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Skin Irritation	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Skin Mass	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Stasis Dermatitis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected86 at risk EG0010 affected14 at risk
Menopause	Social circumstances	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Catheterisation Venous	Surgical and medical procedures	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected86 at risk EG0010 affected14 at risk
Flushing	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected86 at risk EG0011 affected14 at risk
Haematoma	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Hot Flush	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected86 at risk EG0010 affected14 at risk
Hypertension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected86 at risk EG0011 affected14 at risk
Hypotension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected86 at risk EG0012 affected14 at risk
Pallor	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Varicose Vein	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk
Venous Thrombosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected86 at risk EG0010 affected14 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama		United States

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

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D001896	Boron Compounds
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

ID	Title	Description
BG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
BG001	Relapsed Multiple Myeloma (RMM)	Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Newly Diagnosed Multiple Myeloma (NDMM)	Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).	9	86	28	86	86	86
EG001	Relapsed Multiple Myeloma (RMM)	Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).	7	14	5	14	14	14

ID	Term
C556306	daratumumab
D003520	Cyclophosphamide
D000069286	Bortezomib
D003907	Dexamethasone