A Clinical Study Using MEDI-551 in Adult Participants Wit... | NCT00983619

ID	Type	Description	Link
2009-016378-34	EudraCT Number

Label	Type	Description	Intervention Names
Part A-MEDI-551 0.5 mg/kg	Experimental	Participants will receive intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.	Drug: MEDI-551
Part A-MEDI-551 1 mg/kg	Experimental	Participants will receive IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.	Drug: MEDI-551
Part A-MEDI-551 2 mg/kg	Experimental	Participants will receive IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.	Drug: MEDI-551
Part A-MEDI-551 4 mg/kg	Experimental	Participants will receive IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.	Drug: MEDI-551
Part A-MEDI-551 8 mg/kg

Name	Type	Description	Arm Group Labels	Other Names
MEDI-551	Drug	MEDI-551 will be administered intravenously (IV) once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation will be observed.

Measure	Description	Time Frame
Optimal Biologic Dose of MEDI-551 for Part A	Optimal biologic dose (OBD) was defined as the dose lower than the maximum tolerated dose (MTD), used for dose expansion. The MTD is defined as the highest dose at which less than equal to (<=) 1 out of 6 participants experience a dose limiting toxicities (DLT) from the time of first administration of MEDI-551 through the first 28-day cycle.	Day 1 to Day 28 of Cycle 1
Highest Protocol-defined Dose for Part B	Highest protocol-defined dose is dose of MEDI-551 in the absence of exceeding the MTD in participants with relapsed or rituximab-refractory chronic lymphocytic leukemia (defined as those with less than a partial response (PR) or progression within 6 months after completing therapy with rituximab). The MTD is defined as the highest dose at which <= 1 out of 6 participants experience a DLT from the time of first administration of MEDI-551 through the first 28-day cycle.	Day 1 to Day 28 of Cycle 1
Highest Protocol-defined Dose for Part C	Highest protocol-defined dose is the dose of MEDI-551 in combination with rituximab at the MTD or the highest protocol-defined dose in the absence of exceeding the MTD in participants with aggressive lymphomas. The MTD is defined as the highest dose at which <= 1 out of 6 participants experience a DLT from the time of first administration of MEDI-551 through the first 28-day cycle.	Day 1 to Day 28 of Cycle 1
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) for Part A, Part B, and Part C	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Measure	Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) for Part D	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Name	Affiliation	Role
Medimmune Inc. Clinical Development	MedImmune LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35249	United States
Research Site

Label	URL
Click here and search for drug information provided by the FDA.	View source
Click here to find results for studies related to marketed products.	View source
Statistical Analysis Plan (SAP)

ID	Title	Description
FG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
FG001	Part A-MEDI-551 1 mg/kg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Dec 3, 2015	Mar 17, 2020

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

Optimal Biologic Dose of MEDI-551 for Part A

Optimal biologic dose (OBD) was defined as the dose lower than the maximum tolerated dose (MTD), used for dose expansion. The MTD is defined as the highest dose at which less than equal to (<=) 1 out of 6 participants experience a dose limiting toxicities (DLT) from the time of first administration of MEDI-551 through the first 28-day cycle.

Dose limiting toxicity evaluable population included all participants in the dose-escalation phase who received at least 1 full cycle of MEDI-551 and completed safety follow-up through the DLT evaluable period (from the time of first administration of MEDI-551 through the first 28-day of cycle 1).

Posted

Number

mg/Kg

Day 1 to Day 28 of Cycle 1

ID	Title	Description
OG000	Part A-MEDI-551 Part A	Participants received IV infusion of MEDI 551 0.5 or 1 mg/kg (both, once every week in 4-week cycles), or 2, or 4, or 8, or 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Units	Counts
Participants	OG00095

Title

Denominators

Categories

Title	Measurements
	OG00012

Primary

Highest Protocol-defined Dose for Part B

Highest protocol-defined dose is dose of MEDI-551 in the absence of exceeding the MTD in participants with relapsed or rituximab-refractory chronic lymphocytic leukemia (defined as those with less than a partial response (PR) or progression within 6 months after completing therapy with rituximab). The MTD is defined as the highest dose at which <= 1 out of 6 participants experience a DLT from the time of first administration of MEDI-551 through the first 28-day cycle.

DLT evaluable population included all participants in the dose-escalation phase who received at least 1 full cycle of MEDI-551 and completed safety follow-up through the DLT evaluable period (from the time of first administration of MEDI-551 through the first 28-day of cycle).

Posted

Number

mg/Kg

Day 1 to Day 28 of Cycle 1

ID	Title	Description
OG000	Part B-MEDI-551	Participants received IV infusion of MEDI- 551 6 or 12 mg/kg weekly for 4 weeks during Cycle 1 (both from Days 1, 8, 15, and 22) or 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Units	Counts
Participants

Primary

Highest Protocol-defined Dose for Part C

Highest protocol-defined dose is the dose of MEDI-551 in combination with rituximab at the MTD or the highest protocol-defined dose in the absence of exceeding the MTD in participants with aggressive lymphomas. The MTD is defined as the highest dose at which <= 1 out of 6 participants experience a DLT from the time of first administration of MEDI-551 through the first 28-day cycle.

Posted

Number

mg/kg

Day 1 to Day 28 of Cycle 1

ID	Title	Description
OG000	Part C-MEDI-551 + Rituximab	Participants received IV infusion of MEDI- 551 8 or 12 mg/kg on days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 or 12 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdraws consent.

Units	Counts
Participants

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) for Part A, Part B, and Part C

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Safety population included all participants who received any treatment of MEDI-551.

Posted

Count of Participants

Participants

Day 1 through 90-Day Post Last Dose (Approximately 9 years)

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Number of Participants With Dose Limiting Toxicities of MEDI-551 in Part A, Part B, and Part C

A dose limiting toxicities (DLT) for arm A, B, and C was defined as MEDI-551 (or rituximab for Arm C) treatment-related AE of any toxicity grade that led to an inability to receive a full cycle of MEDI-551 (or rituximab for Arm C) or any Grade 3 or higher toxicity (except Grade 3 fever, transient Grade 3 rigors or chills, Grade 3 tumor lysis syndrome, any Grade 3 or 4 electrolyte alteration, any Grade 3 liver function test elevation,>= Grade 3 or 4 lymphopenia or leukopenia, <= Grade 4 neutropenia, <= Grade 4 thrombocytopenia, <= Grade 4 anemia, and Grade 3 infusion-related reaction and infusion reaction), during DLT evaluable period.

Posted

Count of Participants

Participants

Day 1 to Day 28 of Cycle 1

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part A, Part B, and Part C

Number of participants with clinical laboratory abnormalities reported as TEAEs are reported. Clinical laboratory abnormalities are defined as any abnormal findings in analysis of serum chemistry, hematology, and urine.

Safety population included all participants who received any treatment of MEDI-551.

Posted

Count of Participants

Participants

Day 1 through 90-Day Post Last Dose (Approximately 9 years)

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part A, Part B, and Part C

Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal findings in the vital signs parameters (temperature, blood pressure, pulse rate, respiratory rate, and pulse oximetry).

Safety population included all participants who received any treatment of MEDI-551.

Posted

Count of Participants

Participants

Day 1 through 90-Day Post Last Dose (Approximately 9 years)

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part A, Part B, and Part C

Number of participants with abnormal electrocardiograms (ECGs) reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, and QT intervals from the primary lead of the digital 12-lead ECG.

Safety population included all participants who received any treatment of MEDI-551.

Posted

Count of Participants

Participants

Day 1 through 90-Day Post Last Dose (Approximately 9 years)

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Percentage of Participants With Complete Response for Part B, Part C, and Part D

Complete response (CR) is defined as disappearance of all evidence of disease according to International Working Group criteria (IWG). For nodal masses; fluorodeoxyglucose (FDG)-avid or polyethylene terephthalate (PET) positive prior to therapy; mass of any size permitted if PET negative .Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT). For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry (IHC) was negative.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 1 of all Cycles, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part B-MEDI-551 12 mg/kg

Primary

Percentage of Participants With Partial Response for Part B, Part C, and Part D

The PR is defined as regression of measurable disease and no new sites according to IWG criteria. Nodal masses: >= 50% decrease in sum of the product diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) FDG-avid or PET negative; regression on CT. Spleen and liver: >= 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone marrow: irrelevant if positive prior to therapy.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Number

Percentage of Participants

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part B-MEDI-551 12 mg/kg

Primary

Duration of Complete Response for Part B, Part C, and Part D

Duration of CR is from the first documentation of a CR to the time of progressive disease/relapse according to IWG criteria. The CR is disappearance of all evidence of disease according to IWG criteria. For nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative. Variably FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative. Kaplan-Meier method was used to evaluate duration of CR.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. Duration of CR is calculated for participants with CR.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part B-MEDI-551 12 mg/kg

Primary

Percentage of Participants With Objective Response Rate for Part B, Part C, and Part D

Objective response rate (ORR) is proportion of participants with CR or partial response (PR) as per IWG criteria. CR is disappearance of all evidence of disease. Nodal masses; FDG-avid/PET positive prior to therapy; mass of any size permitted if PET negative. FDG-avid or PET negative; regression to normal size on CT. Spleen; not palpable, nodules disappeared. Bone marrow; infiltrate cleared on repeat biopsy; if unknown by morphology, IHC was negative. PR is regression of measurable disease and no new sites. Nodal masses: >= 50% decrease in sum of the product diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) FDG-avid or PET negative; regression on CT. Spleen and liver: >= 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone marrow: irrelevant if positive prior to therapy.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Duration of Objective Response for Part B, Part C, and Part D

Duration of objective response (DOR) is the first documentation of objective response to the first documented progressive disease (PD) or relapse according to IWG criteria. PD is defined as any new lesion or increase by >=50% of previously involved sites from nadir. For nodal masses: appearance of a new lesion(s) > 1.5 cm in any axis, >= 50% increase in SPD of more than one node, or >= 50% increase in longest diameter of a previously identified node > 1 cm in short axis lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. For spleen: > 50% increase from nadir in the SPD of any previous lesions. For bone marrow: New or recurrent involvement. Kaplan-Meier method was used to evaluate DOR.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. The DOR were calculated for participants with objective response.

Posted

Median

Full Range

Months

Cycle 1 Day 1, then every 2 months during the first year of treatment and then every 6 months until end of treatment (unacceptable toxicity, disease progression, withdraws consent, whichever occurred first) (approximately 9 years)

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Percentage of Participants With Disease Control Rate for Part B, Part C, and Part D

Disease control includes CR, PR, or stable disease (SD) for at least 8 weeks according to IWG criteria. The CR is disappearance of all evidence of disease. Nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative. FDG-avid or PET negative; regression to normal size on CT. Spleen; not palpable, nodules disappeared. Bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative. PR is regression of measurable disease and no new sites. Nodal masses: >= 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. Spleen and liver: >= 50% decrease in SPD of nodules; no increase in size of liver or spleen. For bone marrow: irrelevant if positive prior to therapy. SD is failure to attain CR/PR or PD.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Duration of Disease Control for Part B, Part C, and Part D

Duration of disease control is defined as the time period from start of MEDI-551 administration to the event of PD/relapse. PD is defined as any new lesion or increase by >=50% of previously involved sites from nadir. For nodal masses: appearance of a new lesion(s) > 1.5 cm in any axis, >= 50% increase in SPD of more than one node, or >= 50% increase in longest diameter of a previously identified node > 1 cm in short axis lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. For spleen: > 50% increase from nadir in the SPD of any previous lesions. For bone marrow: New or recurrent involvement. Kaplan-Meier method was used to evaluate duration of disease control.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. Duration of disease control is calculated for the participants with objective response or stable disease response.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Time to Response for Part B, Part C, and Part D

Time to response (TTR) is measured from the start of MEDI-551 administration to the first documentation of response (CR or PR) and assessed in participants who have achieved objective response. Kaplan-Meier method was used to evaluate TTR.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment. TTR were calculated for the participants with objective response.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part B-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Progression Free Survival for Part B, Part C, and Part D

Progression-free survival (PFS) is measured from the start of MEDI-551 treatment until the first documentation of disease progression, relapse or death, whichever occurs first. The PFS was censored on the date of last disease assessment for participants who have no documented PD/relapse or death prior to data cutoff, dropout, or the initiation of alternative anticancer therapy. Kaplan-Meier method was used to evaluate PFS.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part B-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Primary

Overall Survival for Part B, Part C, and Part D

Overall survival (OS) is measured from the start of MEDI-551 treatment until death. For participants who are alive at the end of study or lost to follow-up, OS will be censored on the last date when participants were known to be alive. Kaplan-Meier method was used to evaluate OS.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part B-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) for Part D

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Safety population included all participants who received any treatment of MEDI-551.

Posted

Count of Participants

Participants

Day 1 through 90-Day Post Last Dose (Approximately 9 years)

ID	Title	Description
OG000	Part D-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.

Units	Counts
Participants

Secondary

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Part D

Safety population included all participants who received any treatment of MEDI-551.

Posted

Count of Participants

Participants

Day 1 through 90-Day Post Last Dose (Approximately 9 years)

ID	Title	Description
OG000	Part D-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Abnormal Vital Signs Reported as TEAEs in Part D

Safety population included all participants who received any treatment of MEDI-551.

Posted

Count of Participants

Participants

Day 1 through 90-Day Post Last Dose (Approximately 9 years)

ID	Title	Description
OG000	Part D-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Abnormal Electrocardiograms Reported as TEAEs in Part D

Number of participants with abnormal ECGs reported as TEAEs are reported. Abnormal ECGs are defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, and QT intervals from the primary lead of the digital 12-lead ECG.

Safety population included all participants who received any treatment of MEDI-551.

Posted

Count of Participants

Participants

Day 1 through 90-Day Post Last Dose (Approximately 9 years)

ID	Title	Description
OG000	Part D-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Complete Response for Part A

The CR is defined as disappearance of all evidence of disease according to IWG criteria. For nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative .Variably FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Number

95% Confidence Interval

Percentage of Participants

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Percentage of Participants With Partial Response for Part A

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Number

Percentage of Participants

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Duration of Complete Response for Part A

Duration of CR is from the first documentation of a CR to the time of progressive disease/relapse according to IWG criteria. The CR is disappearance of all evidence of disease. For nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative. Variably FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative. Kaplan-Meier method was used to evaluate duration of CR.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Percentage of Participants With Objective Response Rate for Part A

The ORR is defined as proportion of participants with CR or PR according to IWG criteria. CR is disappearance of all evidence of disease. For nodal masses; FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative. FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if unknown by morphology, IHC was negative. PR is regression of measurable disease and no new sites. For nodal masses: >= 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) FDG-avid or PET negative; regression on CT. For spleen and liver: >= 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. For bone marrow: irrelevant if positive prior to therapy.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Duration of Objective Response for Part A

The DOR is the first documentation of objective response to the first documented PD or relapse according to IWG criteria. PD is defined as any new lesion or increase by >=50% of previously involved sites from nadir. For nodal masses: appearance of a new lesion(s) > 1.5 cm in any axis, >= 50% increase in SPD of more than one node, or >= 50% increase in longest diameter of a previously identified node > 1 cm in short axis lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. For spleen: > 50% increase from nadir in the SPD of any previous lesions. For bone marrow: New or recurrent involvement. Kaplan-Meier method was used to evaluate DOR.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg

Secondary

Percentage of Participants With Disease Control Rate for Part A

Disease control includes CR, PR, or SD for at least 8 weeks according to IWG criteria. The CR is disappearance of all evidence of disease. For nodal masses; FDG -avid or PET positive prior to therapy; mass of any size permitted if PET negative. FDG-avid or PET negative; regression to normal size on CT. For spleen; not palpable, nodules disappeared. For bone marrow; infiltrate cleared on repeat biopsy; if indeterminate by morphology, IHC was negative. PR is regression of measurable disease and no new sites. For nodal masses: >= 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. For spleen and liver: >= 50% decrease in SPD of nodules; no increase in size of liver or spleen. For bone marrow: irrelevant if positive prior to therapy. SD is failure to attain CR/PR or PD.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Number

95% Confidence Interval

Percentage of participants

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Duration of Disease Control for Part A

Duration of disease control is defined as the time period from start of MEDI-551 administration to the event of PD/relapse according to IWG criteria. PD is defined as any new lesion or increase by >=50% of previously involved sites from nadir. For nodal masses: appearance of a new lesion(s) > 1.5 cm in any axis, >= 50% increase in SPD of more than one node, or >= 50% increase in longest diameter of a previously identified node > 1 cm in short axis lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. For spleen: > 50% increase from nadir in the SPD of any previous lesions. For bone marrow: New or recurrent involvement. Kaplan-Meier method was used to evaluate duration of disease control.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001

Secondary

Time to Response for Part A

The TTR is measured from the start of MEDI-551 administration to the first documentation of response (CR or PR) and assessed in participants who have achieved objective response. Kaplan-Meier method was used to evaluate TTR.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg

Secondary

Progression Free Survival for Part A

The PFS is measured from the start of MEDI-551 treatment until the first documentation of disease progression, relapse or death, whichever occurs first. Kaplan-Meier method was used to evaluate PFS. The PFS was censored on the date of last disease assessment for participants who have no documented PD/relapse or death prior to data cutoff, dropout, or the initiation of alternative anticancer therapy.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Overall Survival for Part A

The OS is measured from the start of MEDI-551 treatment until death. For participants who are alive at the end of study or lost to follow-up, OS will be censored on the last date when participants were known to be alive. Kaplan-Meier method was used to evaluate OS.

Evaluable population for efficacy included all participants who received any treatment of MEDI-551 and completed at least one post-baseline disease assessment.

Posted

Median

Full Range

Months

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg

Secondary

Trough Serum Concentration of MEDI-551 by Treatment Cycle

Trough serum concentration (Ctrough) is defined as lowest concentration reached by a drug before the next dose is administered. The Ctrough concentration of MEDI-551 by treatment cycle is reported.

Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551. The "Number of Participants Analyzed" denotes the number of participants evaluated for specific day.

Posted

Mean

Standard Deviation

μg/mL

For Part A: C1D1 of each cycles; For Part B: C1D1 of each cycle + C1D8, C1D15, and C1D22; For Part C: C1D2, C1D8, then Day 1 of each cycle until Cycle 10;For Part D: C1D1, C1D8, then Day 1 of each cycle until Cycle 10

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg

Secondary

Peak Serum Concentration of MEDI-551 by Treatment Cycle

Peak serum concentration is concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.

Posted

Mean

Standard Deviation

μg/mL

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg

Secondary

Area Under the Concentration Curve at Steady State (AUCss) of MEDI-551

Area under the concentration-time curve at steady state (Css, AUC) of MEDI-551 is reported.

Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551.

Posted

Mean

Standard Deviation

μg⋅day/mL

Part A:Cycle(C)1 Day(D)1 (Pre & post dose [PPD] 2,6,24,48 hrs PD); PPD once a week in 4 weeks C till C71; Part B:C1 (D1,D8,D15,D22),PPD of D1 of each C till C28; Part C & D:PPD of C1 (D2,D8), predose D15 and 22, PPD of D1 of each C till C24

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Apparent Clearance of MEDI-551

Apparent clearance of MEDI-551 is reported.

Population pharmacokinetic model included all participants who received at least one dose of MEDI-551 and provided at least one measurable serum concentration of MEDI-551.

Posted

Mean

Standard Deviation

mL/day

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Volume of Distribution of MEDI-551

Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Central volume of distribution (Vd1) is defined as hypothetical volume into which a drug initially distributes upon administration and peripheral volume of distribution (Vd2) is defined as the sum of all tissue spaces outside the central compartment.

Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551.

Posted

Mean

Standard Deviation

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Terminal Half-life (t1/2) of MEDI-551

Terminal half-life is the time required for the plasma concentration of MEDI-551 to fall by 50% during the terminal phase.

Pharmacokinetic population included all participants who received at least one dose of MEDI-551 and had at least one measurable serum concentration of MEDI-551.

Posted

Mean

Standard Deviation

Days

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Number of Participants With Positive Anti-drug Antibodies (ADA) Titer to MEDI-551

Number of participants with positive Anti-drug antibodies (ADA) titer to MEDI-551 is reported.

Safety population included all participants who received any treatment of MEDI-551. Participants only with positive ADA is reported.

Posted

Count of Participants

Participants

Part A:C1D1; Part B: C1D1; Part C: C1D1; Part D: C1D1; End of treatment (EOT); 90 Days post last dose (approximately 9 years)

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

B-cell Concentration in Serum

B-cell Concentration in serum is reported.

Safety population included all participants who received any treatment of MEDI-551. It was pre-specified that B-cell analysis was not required, due to limited data availability.

Posted

Part A:C1D1 of each cycles; Part B: C1D1 of each cycle + C1D8, C1D15, and C1D22; Part C: C1D2, C1D8, then Day 1 of each cycle until Cycle 10; Part D: C1D1, C1D8, Day 1 of each cycle until Cycle 10; EOT;90 Days post last dose (approximately 9 years)

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Secondary

Immunoglobulin (Ig) Concentration in Serum

Immunoglobin (Ig) concentration in serum is reported.

Safety population included all participants who received any treatment of MEDI-551.

Posted

Mean

Standard Deviation

mg/dL

Part A:C1D1 of each cycles; EOT;90 Days post last dose (approximately 9 years)

ID	Title	Description
OG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
OG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG0030 events0 affected6 at risk EG0040 events0 affected3 at risk EG0050 events0 affected76 at risk EG0060 events0 affected3 at risk EG0070 events0 affected3 at risk EG0080 events0 affected1 at risk EG0090 events0 affected3 at risk EG0100 events0 affected17 at risk EG0111 events1 affected14 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Abscess limb	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Varicella	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Diffuse large b-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cauda equina syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Toxic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected4 at risk EG0020 events0 affected3 at risk EG0030 events0 affected6 at risk EG0041 events1 affected3 at risk EG0058 events6 affected76 at risk EG0060 events0 affected3 at risk EG0071 events1 affected3 at risk EG0082 events1 affected1 at risk EG0090 events0 affected3 at risk EG01018 events4 affected17 at risk EG0113 events2 affected14 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypergammaglobulinaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Lymph node pain	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Polycythaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Palpitations	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Ear swelling	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Excessive cerumen production	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Otorrhoea	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dry eye	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Exophthalmos	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Eye pruritus	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Glaucoma	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Vision blurred	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events2 affected4 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Anal incontinence	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0015 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00010 events3 affected3 at risk EG0014 events2 affected4 at risk EG0021 events1 affected3 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Tongue coated	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Breakthrough pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Chills	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cyst	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Early satiety	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0015 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
Gait disturbance	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Gravitational oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Ill-defined disorder	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Influenza like illness	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Infusion site pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Localised oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Malaise	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Mass	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Medical device site bruise	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Medical device site pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Mucosal inflammation	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Necrosis	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Performance status decreased	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Peripheral swelling	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Immune system disorder	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Abscess limb	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
Candida infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Ear infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Furuncle	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Laryngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Oral herpes	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rash pustular	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rhinitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Tooth infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0022 events1 affected3 at risk EG003
Viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood albumin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood chloride decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood cholesterol increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood creatinine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Blood fibrinogen decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood fibrinogen increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood immunoglobulin m decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood iron decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood potassium decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0005 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blood urea increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
C-reactive protein increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
Electrocardiogram qt prolonged	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Glucose urine present	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Haematocrit decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Karnofsky scale worsened	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0014 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Mean cell volume increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Neutrophil count abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected3 at risk EG0015 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Occult blood positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Platelet count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Prostatic specific antigen increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Protein total decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Red blood cell count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Serum ferritin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Vitamin d decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Weight decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Weight increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
White blood cell count decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected4 at risk EG0021 events1 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0016 events2 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0016 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected3 at risk EG0012 events2 affected4 at risk EG0020 events0 affected3 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Sarcopenia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Metastatic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Amnesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Anosmia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Somnolence	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Tremor	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Device dislocation	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Aggression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Agitation	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hallucinations, mixed	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Bladder spasm	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Haemoglobinuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Urine flow decreased	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Breast swelling	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Haematospermia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Nipple disorder	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events2 affected4 at risk EG0020 events0 affected3 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
Increased bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0021 events1 affected3 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Erythema annulare	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Macule	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Scab	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Solar lentigo	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Ex-tobacco user	Social circumstances	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Flushing	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hot flush	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events3 affected4 at risk EG0021 events1 affected3 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0021 events1 affected3 at risk EG003
Phlebitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected4 at risk EG0020 events0 affected3 at risk EG003
Systolic hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected4 at risk EG0020 events0 affected3 at risk EG003

ID	Title	Description
BG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG003	Part A-MEDI-551 4 mg/kg	Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG004	Part A-MEDI-551 8 mg/kg	Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG005	Part A-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG006	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG007	Part B-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG008	Part B-MEDI-551 24 mg/kg	Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.
BG009	Part C-MEDI-551 8 mg/kg + Rituximab	Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
BG010	Part C-MEDI-551 12 mg/kg + Rituximab	Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.
BG011	Part D-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.
BG012	TOTAL	Total of all reporting groups

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A-MEDI-551 0.5 mg/kg	Participants received intravenous (IV) infusion of MEDI 551 0.5 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	0	3	1	3	3	3
EG001	Part A-MEDI-551 1 mg/kg	Participants received IV infusion of MEDI 551 1 mg/kg once every week in 4-week cycles until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	2	4	1	4	4	4
EG002	Part A-MEDI-551 2 mg/kg	Participants received IV infusion of MEDI 551 2 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	2	3	2	3	3	3
EG003	Part A-MEDI-551 4 mg/kg	Participants received IV infusion of MEDI 551 4 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	1	6	1	6	6	6
EG004	Part A-MEDI-551 8 mg/kg	Participants received IV infusion of MEDI 551 8 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	2	3	1	3	3	3
EG005	Part A-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI 551 12 mg/kg on Days 1 and 8 of Cycle 1 (loading doses) and then once every 28 days at the start of each subsequent cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	30	76	23	76	75	76
EG006	Part B-MEDI-551 6 mg/kg	Participants received IV infusion of MEDI- 551 6 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	1	3	1	3	3	3
EG007	Part B-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI- 551 12 mg/kg weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and thereafter from Cycle 2 on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	0	3	2	3	3	3
EG008	Part B-MEDI-551 24 mg/kg	Participants received IV infusion of MEDI- 551 24 mg/kg weekly for 4 weeks during Cycle 1 (over 2 days on Day 1 and Day 2, and on Days 8, 15, and 22) and thereafter from Cycle 2, on Day 1 of each 28-day cycle until complete response, disease progression, toxicity, or another reason for treatment discontinuation was observed.	1	1	1	1	1	1
EG009	Part C-MEDI-551 8 mg/kg + Rituximab	Participants received IV infusion of MEDI- 551 8 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.	2	3	1	3	3	3
EG010	Part C-MEDI-551 12 mg/kg + Rituximab	Participants received IV infusion of MEDI- 551 12 mg/kg on Days 2 and 8 during Cycle 1 and on Day 1 during Cycle 2 (28-day cycle) in combination with rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. From Cycle 3 onwards, only MEDI- 551 8 mg/kg was administered on Day 1 of each 28-day cycle. The treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached complete response or withdrew consent.	9	17	9	17	17	17
EG011	Part D-MEDI-551 12 mg/kg	Participants received IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and thereafter Day 1 of 28- day cycles from Cycle 2 onwards. Treatment was continued until the participants experienced unacceptable toxicity, disease progression, reached CR or withdrew consent.	8	14	5	14	14	14