Study Comparing Daratumumab, Lenalidomide, and Dexamethas... | NCT02252172

ID	Type	Description	Link
54767414MMY3008	Other Identifier	Janssen Research & Development, LLC
2014-002273-11	EudraCT Number

Label	Type	Description	Intervention Names
Lenalidomide and Dexamethasone (Rd)	Active Comparator	Participants will receive Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.	Drug: Daratumumab IV Drug: Lenalidomide Drug: Dexamethasone
Daratumumab + Lenalidomide + Dexamethasone (DRd)	Active Comparator	Participants will receive Daratumumab 16 milligram per kilogram (mg/kg) by intravenous infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks, Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously once a week. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator. Daratumumab subcutaneous (SC) will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study completion. Study treatment continues until disease progression, unacceptable toxicity, or end of study (maximum up to 7 years after last subject is randomized) whichever comes first.	Drug: Lenalidomide Drug: Dexamethasone Drug: Daratumumab SC

Name	Type	Description	Arm Group Labels	Other Names
Daratumumab IV	Drug	Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).

Measure	Description	Time Frame
Progression-free Survival (PFS)	PFS was defined as time from date of randomization to either progressive disease (PD) or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD was defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [>]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that could be attributed solely to Plasma cell (PC) proliferative disorder.	From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)

Measure	Description	Time Frame
Percentage of Participants With Complete Response (CR) or Better	Percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria was reported. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio was required. sCR was defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence, 2-4 color flow cytometry (FC).

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
42085642	Derived	Bahlis N, Facon T, San-Miguel J, Usmani SZ, Dimopoulos MA, Moreau P, Zweegman S, Perrot A, Manier S, Chari A, Raje N, Orlowski RZ, Goldschmidt H, Basu S, Hulin C, Weisel K, Mohty M, Leleu X, Plesner T, Jakubowiak A, Cook G, Quach H, Venner CP, Cavo M, Ngo M, Bolyard K, Carson R, Borgsten F, Mateos MV, Kumar SK. Infections in patients receiving daratumumab for newly diagnosed multiple myeloma: a pooled analysis of MAIA and ALCYONE. Blood Adv. 2026 Jul 14;10(13):4541-4550. doi: 10.1182/bloodadvances.2025019323.
40016302

ID	Title	Description
FG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 21, 2021	Oct 1, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-free Survival (PFS)

PFS was defined as time from date of randomization to either progressive disease (PD) or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD was defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [>]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that could be attributed solely to Plasma cell (PC) proliferative disorder.

Intent-to-treat (ITT) population included all randomized participants.

Posted

Median

95% Confidence Interval

Months

From randomization (Day -3) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

Units	Counts
Participants	OG000369 OG001368

Title

Denominators

Categories

Title	Measurements
	OG00031.87(28.94 to NA)Here NA signifies upper limit of confidence interval (CI) was not estimable due to an insufficient number of events. OG001NA(NA to NA)Here 'NA' signifies median and CI was not estimable due to an insufficient number of events.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.0001		Hazard Ratio (HR)	0.56			2-Sided	95	0.43	0.73					Superiority

Secondary

Percentage of Participants With Complete Response (CR) or Better

Percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria was reported. CR was defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio was required. sCR was defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence, 2-4 color flow cytometry (FC).

ITT population included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

Secondary

Percentage of Participants With Very Good Partial Response (VGPR) or Better

VGPR or better rate was defined as the percentage of participants who achieved VGPR or better (VGPR, CR or sCR) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC.

ITT population included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)

Secondary

Percentage of Participants With Negative Minimal Residual Disease (MRD)

MRD negativity rate is defined as the percentage of participants who had negative MRD at any time point after the date of randomization and prior to subsequent antimyeloma therapy. MRD was assessed in participants who achieved CR or better.

ITT population included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

Secondary

Percentage of Participants With Stringent Complete Response (sCR)

sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by IHC, immunofluorescence or 2- to 4-color FC. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; <5% PCs in bone marrow.

Intent-to-treat (ITT) population included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

Secondary

Overall Response Rate (ORR)

ORR was the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If serum and urine M-protein were not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria. If present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas was also required. VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC.

ITT population included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).

Secondary

Overall Survival (OS)

OS was measured from the date of randomization to the date of the death. Median OS was estimated by using the Kaplan-Meier method.

ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

Months

From randomization (Day -3) up to 8.7 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

Secondary

Time to Disease Progression (TTP)

TTP was defined as the time from the date of randomization to date of first documented evidence of PD or death due to PD, whichever occurred first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase >=0.5 g/dL); Urine M-component (absolute increase >=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Definite development of new bone lesions/soft tissue plasmacytomas or 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.

ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

Months

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)

Secondary

Time to Response

Time to first response, time to VGPR or better, time to CR or better and time to best response was reported for this endpoint. Time to response: time from date of randomization to first efficacy evaluation that met criteria for PR/better as their best response (PR, CR, or better) based on IMWG criteria. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If serum and urine M-protein were not measurable, a decrease of >=50% in difference between involved and uninvolved FLC levels was required in place of M-protein criteria. Based on computerized algorithm, according to IMWG response criteria, VGPR or better: proportion of participants with a response of VGPR or better (i.e., VGPR, CR or sCR), CR or better: proportion of participants with a response of CR or better (i.e., CR or sCR).

Response evaluable population included all participants with confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit and received at least one administration of study treatment and had adequate postbaseline disease assessments. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.

Posted

Median

Full Range

Months

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).

Secondary

Duration of Response (DoR)

DoR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase >=0.5 g/dL); Urine M-component (absolute increase >=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Definite development of new bone lesions/soft tissue plasmacytomas or 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.

Response evaluable population included all participants with confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit and received at least one administration of study treatment and had adequate postbaseline disease assessments. Here, 'N' (Overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

Months

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).

Secondary

Time to Subsequent Anti-myeloma Treatment

Time to subsequent anti-myeloma treatment was defined as the time from randomization to the start of subsequent anti-myeloma treatment. Kaplan-Meier method was used for the analysis.

Intent-to-treat (ITT) population included all randomized participants.

Posted

Median

95% Confidence Interval

Months

From randomization (Day -3) up to 8.7 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

Secondary

Progression-free Survival on Next Line of Therapy (PFS2)

PFS2 was defined as the time from randomization to progression on next line of therapy or death, whichever comes first. Disease progression on next line of treatment was based on investigator judgment.

Intent-to-treat (ITT) population included all randomized participants.

Posted

Median

95% Confidence Interval

Months

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score

EORTC QLQ-C30 was 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire included 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores were transformed to 0 to 100 scale, with higher scores represented better GHS and functioning, and more symptoms. Negative change from baseline values showed deterioration in quality of life or functioning and reduction in symptom and positive values indicated improvement and worsening of symptoms.

ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.

Posted

Least Squares Mean

95% Confidence Interval

Score on scale

Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days)

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).

Secondary

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)

EQ-5D-5L was a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale was designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.

ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' signifies number of participants analyzed at specified timepoints.

Posted

Least Squares Mean

95% Confidence Interval

Score on scale

Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days)

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
OG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)

Secondary

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score

EQ-5D-5L was standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L included 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provided a profile of participant's health state 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflected increasing levels of difficulty. Participants indicated their health state by selecting the most appropriate level in each of the 5D. Responses to the 5D scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom scoring algorithm). Higher score indicated better health state.

ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' signifies number of participants analyzed at specified timepoints.

Posted

Least Squares Mean

95% Confidence Interval

Score on scale

Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days)

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).

Secondary

Sub-group Analysis: Progression-free Survival (PFS)

PFS for participants with cytogenic high risk was reported. PFS was time from date of randomization to either PD or death, whichever occurred first based on computerized algorithm as per IMWG criteria. PD: an increase of 25% from lowest response value in one of following: serum and urine M-component (absolute increase must be >=0.5 g/dL and >=200 mg/24h respectively); Only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute >10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that could be attributed solely to PC proliferative disorder. High risk was defined as positive for any of del17p, t(14;16) or t(4;14) by (corrected serum calcium >11.5 mg/dL) Fluorescence In Situ Hybridization (FISH)/Karyotype.

Intent-to-treat (ITT) population included all randomized participants. Here, 'N' signifies number of participants evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

Months

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).

Secondary

Sub-group Analysis: Overall Response Rate (ORR)

ORR for participants with cytogenic high risk was reported. ORR: percentage of participants who achieved PR/better per IMWG criteria. PR: >=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90% or <200mg/24h. If serum/urine M-protein were not measurable, decrease of >=50% in difference between involved and uninvolved FLC levels was required in place of M-protein criteria. If present at baseline, >=50% reduction in size of soft tissue plasmacytomas was required. VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis or >=90% reduction in serum and urine M-protein <100mg/24h. CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% PCs in bone marrow; sCR: CR in addition to normal FLC ratio, absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC. High risk: positive for any of del17p, t(14;16) or t(4;14) by FISH/Karyotype.

Intent-to-treat (ITT) population included all randomized participants. Here, 'N' signifies number of participants evaluable for this outcome measure.

Posted

Number

Percentage of participants

From randomization (Day -3) up to 6.6 years

ID	Title	Description
OG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).

Serious 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 affected365 at risk EG0016 affected364 at risk
Anaemia Macrocytic	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Blood Loss Anaemia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Disseminated Intravascular Coagulation	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected365 at risk EG00111 affected364 at risk
Heparin-Induced Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0013 affected364 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0011 affected364 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00015 affected365 at risk EG00110 affected364 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0013 affected364 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Atrioventricular Block	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Bradycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0010 affected364 at risk
Cardiac Amyloidosis	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0013 affected364 at risk
Cardiac Failure	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected365 at risk EG0015 affected364 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0013 affected364 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0013 affected364 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Hypertensive Heart Disease	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0012 affected364 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Myocarditis	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Pericardial Effusion	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Sinus Node Dysfunction	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Stress Cardiomyopathy	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Corneal Dystrophy	Congenital, familial and genetic disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Deafness Bilateral	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0012 affected364 at risk
Adrenal Insufficiency	Endocrine disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Hypothyroidism	Endocrine disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Blepharitis	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Cataract	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0014 affected364 at risk
Retinal Artery Occlusion	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Retinal Detachment	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Retinal Vein Thrombosis	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0015 affected364 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Anal Fissure	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Colitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0012 affected364 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0014 affected364 at risk
Dental Caries	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected365 at risk EG00111 affected364 at risk
Diarrhoea Haemorrhagic	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Diverticular Perforation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0015 affected364 at risk
Diverticulum	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Diverticulum Intestinal Haemorrhagic	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Enterovesical Fistula	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Faecaloma	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Gastric Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0012 affected364 at risk
Haematochezia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0018 affected364 at risk
Inguinal Hernia Strangulated	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Large Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Melaena	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0011 affected364 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0015 affected364 at risk
Obstruction Gastric	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Obstructive Pancreatitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Oesophageal Achalasia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Oesophageal Rupture	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0011 affected364 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Subileus	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Toothache	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0016 affected364 at risk
Asthenia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected365 at risk EG0016 affected364 at risk
Chest Discomfort	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0010 affected364 at risk
Chills	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Extravasation	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Fatigue	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0014 affected364 at risk
General Physical Health Deterioration	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected365 at risk EG0013 affected364 at risk
Granuloma	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Influenza Like Illness	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Malaise	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0012 affected364 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0017 affected364 at risk
Oedema Peripheral	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Peripheral Swelling	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Physical Deconditioning	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Procedural Failure	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Pyrexia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected365 at risk EG00120 affected364 at risk
Sudden Cardiac Death	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Sudden Death	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0011 affected364 at risk
Systemic Inflammatory Response Syndrome	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Acute Hepatic Failure	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0013 affected364 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0016 affected364 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Cholestasis	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Drug-Induced Liver Injury	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Hepatic Failure	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Hepatocellular Injury	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Amyloidosis	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Abdominal Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Anal Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Appendicitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Appendicitis Perforated	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Arthritis Bacterial	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Arthritis Infective	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Bacteraemia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Bacterial Diarrhoea	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Bacterial Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Bronchiolitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Bronchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected365 at risk EG00115 affected364 at risk
Campylobacter Gastroenteritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Campylobacter Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Cellulitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0015 affected364 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Colonic Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Coronavirus Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Covid-19	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0016 affected364 at risk
Covid-19 Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Cystitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Cytomegalovirus Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Device Related Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Diverticulitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0017 affected364 at risk
Encephalitis Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Endocarditis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Endocarditis Staphylococcal	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Erysipelas	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0015 affected364 at risk
Escherichia Bacteraemia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Escherichia Pyelonephritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Escherichia Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Escherichia Urinary Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Gastrointestinal Viral Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Groin Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0011 affected364 at risk
Haematoma Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Infected Cyst	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Influenza	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected365 at risk EG00117 affected364 at risk
Kidney Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Klebsiella Bacteraemia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Klebsiella Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Laryngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Listeriosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Localised Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected365 at risk EG00111 affected364 at risk
Lower Respiratory Tract Infection Bacterial	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Lower Respiratory Tract Infection Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Metapneumovirus Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Myocarditis Infectious	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Neutropenic Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Neutropenic Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Nocardiosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Oesophageal Candidiasis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Orchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0011 affected364 at risk
Otitis Externa	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Parainfluenzae Virus Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Peritonitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Pharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pleural Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pneumocystis Jirovecii Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pneumocystis Jirovecii Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00039 affected365 at risk EG00168 affected364 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Pneumonia Klebsiella	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pneumonia Pneumococcal	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Pneumonia Respiratory Syncytial Viral	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pulmonary Mycosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Respiratory Syncytial Virus Bronchiolitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Respiratory Syncytial Virus Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0011 affected364 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Salmonellosis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected365 at risk EG00111 affected364 at risk
Sepsis Syndrome	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Septic Arthritis Staphylococcal	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Septic Embolus	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Septic Shock	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0016 affected364 at risk
Skin Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Soft Tissue Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Spinal Cord Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Streptococcal Sepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0016 affected364 at risk
Ureteritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected365 at risk EG00112 affected364 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Urosepsis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Varicella	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Varicella Zoster Virus Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Vascular Device Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Vestibular Neuronitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Vulval Abscess	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Accident	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Acetabulum Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Animal Bite	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Arteriovenous Fistula Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Craniocerebral Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Face Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Facial Bones Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected365 at risk EG0019 affected364 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0016 affected364 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0019 affected364 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0015 affected364 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Limb Traumatic Amputation	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Open Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0012 affected364 at risk
Periorbital Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Periprosthetic Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Post Procedural Fever	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Post-Traumatic Pain	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0016 affected364 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Sternal Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Traumatic Intracranial Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Ulna Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Wound Necrosis	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
C-Reactive Protein Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
General Physical Condition Abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
International Normalised Ratio Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Lipase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Occult Blood Positive	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Oxygen Saturation Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Radial Pulse Abnormal	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Transaminases Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Troponin I Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0016 affected364 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Failure to Thrive	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0011 affected364 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0011 affected364 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0013 affected364 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0013 affected364 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected365 at risk EG0013 affected364 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0012 affected364 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Type 1 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0014 affected364 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0014 affected364 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected365 at risk EG00114 affected364 at risk
Bone Lesion	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected365 at risk EG0014 affected364 at risk
Bone Sequestrum	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Chondrocalcinosis Pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Crystal Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Intervertebral Disc Compression	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Jaw Fistula	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Mobility Decreased	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0015 affected364 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0012 affected364 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0014 affected364 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Osteonecrosis of Jaw	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0011 affected364 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Pathological Fracture	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Spinal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0013 affected364 at risk
Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Spinal Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Adenocarcinoma Gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Adenocarcinoma of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Adrenal Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
B Precursor Type Acute Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0016 affected364 at risk
Bowen's Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Cancer Pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Colorectal Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Diffuse Large B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Gastrointestinal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Gastrointestinal Stromal Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Intraductal Proliferative Breast Lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Invasive Lobular Breast Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Mantle Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Metastatic Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Metastatic Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Mucinous Adenocarcinoma of Appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Neuroendocrine Carcinoma of the Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Non-Hodgkin's Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Non-Small Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Ovarian Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Porocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Primary Pulmonary Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Prostatic Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Rectal Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Skin Squamous Cell Carcinoma Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Small Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Squamous Cell Carcinoma of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected365 at risk EG0017 affected364 at risk
Superficial Spreading Melanoma Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Balance Disorder	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Brain Oedema	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Brain Stem Infarction	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Cerebral Infarction	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0011 affected364 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0015 affected364 at risk
Cognitive Disorder	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Dementia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Dementia Alzheimer's Type	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Dizziness	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0013 affected364 at risk
Encephalopathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Epilepsy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Focal Dyscognitive Seizures	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Generalised Tonic-Clonic Seizure	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Headache	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Hepatic Encephalopathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Hyperaesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Ischaemic Cerebral Infarction	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0012 affected364 at risk
Nervous System Disorder	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Neuralgia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Occipital Neuralgia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Orthostatic Intolerance	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Peripheral Motor Neuropathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Post Herpetic Neuralgia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Presyncope	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0011 affected364 at risk
Radiculopathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Sciatica	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0014 affected364 at risk
Seizure	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0015 affected364 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0011 affected364 at risk
Syncope	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0016 affected364 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0012 affected364 at risk
Vertebrobasilar Stroke	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Vith Nerve Paralysis	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Device Dislocation	Product Issues	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Agitation	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Completed Suicide	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Confusional State	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0014 affected364 at risk
Depression	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Eating Disorder	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Major Depression	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Mental Status Changes	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0013 affected364 at risk
Personality Change	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00015 affected365 at risk EG00114 affected364 at risk
Bladder Neck Sclerosis	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Bladder Stenosis	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Dysuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Pollakiuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Renal Disorder	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0016 affected364 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Urethral Caruncle	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Urinary Retention	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG0012 affected364 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Cystocele	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Genital Prolapse	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Hysterocele	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0013 affected364 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0014 affected364 at risk
Bronchial Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0011 affected364 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0007 affected365 at risk EG0016 affected364 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG0016 affected364 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pleuritic Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00014 affected365 at risk EG00116 affected364 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Pulmonary Thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Acute Febrile Neutrophilic Dermatosis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Dermatitis Exfoliative Generalised	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Drug Reaction with Eosinophilia and Systemic Symptoms	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0010 affected364 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0011 affected364 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected365 at risk EG0010 affected364 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Stevens-Johnson Syndrome	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Air Embolism	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Aortic Aneurysm	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Aortic Aneurysm Rupture	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Aortic Stenosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Arteritis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected365 at risk EG0016 affected364 at risk
Embolism	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0012 affected364 at risk
Haematoma	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0004 affected365 at risk EG0011 affected364 at risk
Haemorrhage	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Hypertension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0013 affected364 at risk
Hypotension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0013 affected364 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0001 affected365 at risk EG0010 affected364 at risk
Peripheral Artery Stenosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0012 affected364 at risk
Phlebitis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0011 affected364 at risk
Superior Vena Cava Occlusion	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0000 affected365 at risk EG0011 affected364 at risk
Venous Thrombosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0002 affected365 at risk EG0010 affected364 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	EG000148 affected365 at risk EG001154 affected364 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00042 affected365 at risk EG00173 affected364 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00048 affected365 at risk EG00172 affected364 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG000167 affected365 at risk EG001224 affected364 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00076 affected365 at risk EG00182 affected364 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00033 affected365 at risk EG00130 affected364 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00019 affected365 at risk EG00122 affected364 at risk
Cataract	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00078 affected365 at risk EG00188 affected364 at risk
Vision Blurred	Eye disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00019 affected365 at risk EG00130 affected364 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00043 affected365 at risk EG00159 affected364 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00030 affected365 at risk EG00141 affected364 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG000136 affected365 at risk EG001156 affected364 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG000186 affected365 at risk EG001237 affected364 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00021 affected365 at risk EG00114 affected364 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00031 affected365 at risk EG00131 affected364 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00024 affected365 at risk EG00124 affected364 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected365 at risk EG00119 affected364 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00087 affected365 at risk EG001133 affected364 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00013 affected365 at risk EG00125 affected364 at risk
Toothache	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00020 affected365 at risk EG00120 affected364 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00048 affected365 at risk EG00177 affected364 at risk
Asthenia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00099 affected365 at risk EG001134 affected364 at risk
Chills	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0006 affected365 at risk EG00149 affected364 at risk
Fatigue	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG000114 affected365 at risk EG001163 affected364 at risk
Influenza Like Illness	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected365 at risk EG00122 affected364 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00021 affected365 at risk EG00123 affected364 at risk
Oedema Peripheral	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG000117 affected365 at risk EG001156 affected364 at risk
Peripheral Swelling	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00024 affected365 at risk EG00116 affected364 at risk
Pyrexia	General disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00063 affected365 at risk EG00185 affected364 at risk
Hypogammaglobulinaemia	Immune system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0003 affected365 at risk EG00119 affected364 at risk
Bronchitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00085 affected365 at risk EG001119 affected364 at risk
Cystitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected365 at risk EG00123 affected364 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00022 affected365 at risk EG00136 affected364 at risk
Influenza	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00022 affected365 at risk EG00131 affected364 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00018 affected365 at risk EG00121 affected364 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00066 affected365 at risk EG00192 affected364 at risk
Pneumonia	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00036 affected365 at risk EG00164 affected364 at risk
Rhinitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00023 affected365 at risk EG00138 affected364 at risk
Sinusitis	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected365 at risk EG00126 affected364 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00052 affected365 at risk EG00193 affected364 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 23.0	Non-systematic Assessment	EG00044 affected365 at risk EG00177 affected364 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG00032 affected365 at risk EG00137 affected364 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 23.0	Non-systematic Assessment	EG00025 affected365 at risk EG00143 affected364 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG00015 affected365 at risk EG00121 affected364 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected365 at risk EG00120 affected364 at risk
Blood Creatinine Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG00021 affected365 at risk EG00135 affected364 at risk
Weight Decreased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG00070 affected365 at risk EG001115 affected364 at risk
Weight Increased	Investigations	MedDRA Version 23.0	Non-systematic Assessment	EG0008 affected365 at risk EG00129 affected364 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00065 affected365 at risk EG00193 affected364 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00018 affected365 at risk EG00123 affected364 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected365 at risk EG00119 affected364 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00028 affected365 at risk EG00154 affected364 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected365 at risk EG00119 affected364 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00035 affected365 at risk EG00159 affected364 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00072 affected365 at risk EG001100 affected364 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00032 affected365 at risk EG00130 affected364 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00016 affected365 at risk EG00120 affected364 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected365 at risk EG00122 affected364 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00078 affected365 at risk EG001107 affected364 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG000107 affected365 at risk EG001147 affected364 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00035 affected365 at risk EG00142 affected364 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00086 affected365 at risk EG001111 affected364 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00025 affected365 at risk EG00140 affected364 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00045 affected365 at risk EG00139 affected364 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00057 affected365 at risk EG00173 affected364 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00028 affected365 at risk EG00134 affected364 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00033 affected365 at risk EG00131 affected364 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00021 affected365 at risk EG00130 affected364 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00060 affected365 at risk EG00182 affected364 at risk
Spinal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00019 affected365 at risk EG00117 affected364 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected365 at risk EG00122 affected364 at risk
Dizziness	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00065 affected365 at risk EG00179 affected364 at risk
Dysgeusia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected365 at risk EG00129 affected364 at risk
Headache	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00043 affected365 at risk EG00179 affected364 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected365 at risk EG00123 affected364 at risk
Memory Impairment	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected365 at risk EG00120 affected364 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00031 affected365 at risk EG00167 affected364 at risk
Peripheral Sensory Neuropathy	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00066 affected365 at risk EG001111 affected364 at risk
Sciatica	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00019 affected365 at risk EG00126 affected364 at risk
Taste Disorder	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00019 affected365 at risk EG00114 affected364 at risk
Tremor	Nervous system disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00053 affected365 at risk EG00164 affected364 at risk
Agitation	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected365 at risk EG00120 affected364 at risk
Anxiety	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00038 affected365 at risk EG00139 affected364 at risk
Confusional State	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00020 affected365 at risk EG00129 affected364 at risk
Depression	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00038 affected365 at risk EG00137 affected364 at risk
Insomnia	Psychiatric disorders	MedDRA Version 23.0	Non-systematic Assessment	EG000116 affected365 at risk EG001125 affected364 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00017 affected365 at risk EG00134 affected364 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00023 affected365 at risk EG00137 affected364 at risk
Dysuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected365 at risk EG00120 affected364 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG00119 affected364 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00035 affected365 at risk EG00134 affected364 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00065 affected365 at risk EG001123 affected364 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00019 affected365 at risk EG00129 affected364 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00064 affected365 at risk EG001115 affected364 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00025 affected365 at risk EG00129 affected364 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00020 affected365 at risk EG00121 affected364 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected365 at risk EG00123 affected364 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected365 at risk EG00131 affected364 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00011 affected365 at risk EG00123 affected364 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00012 affected365 at risk EG00130 affected364 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00021 affected365 at risk EG00130 affected364 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00022 affected365 at risk EG00131 affected364 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0005 affected365 at risk EG00123 affected364 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00020 affected365 at risk EG00114 affected364 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00035 affected365 at risk EG00141 affected364 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00070 affected365 at risk EG00172 affected364 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00010 affected365 at risk EG00123 affected364 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA Version 23.0	Non-systematic Assessment	EG0009 affected365 at risk EG00119 affected364 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00030 affected365 at risk EG00132 affected364 at risk
Haematoma	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00023 affected365 at risk EG00131 affected364 at risk
Hypertension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00031 affected365 at risk EG00165 affected364 at risk
Hypotension	Vascular disorders	MedDRA Version 23.0	Non-systematic Assessment	EG00033 affected365 at risk EG00142 affected364 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

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

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

ID	Title	Description
BG000	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).
BG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
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	Lenalidomide + Dexamethasone (Rd)	Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group [IMWG] criteria).	259	369	262	365	358	365
EG001	Daratumumab + Lenalidomide + Dexamethasone (DRd)	Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).	287	368	289	364	362	364