Open Label Controlled Trial of Eculizumab in Adult Patien... | NCT00838513

NCT00838513

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
eculizumab	Experimental		Drug: eculizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
eculizumab	Drug	All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients With TMA Event-free Status	TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.	Through 26 weeks
Percentage of Patients With Hematologic Normalization	Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.	Through 26 weeks
Percentage of Patients With Complete TMA Response	The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.	Through 26 weeks

Secondary Outcomes

Measure	Description	Time Frame
TMA Intervention Rate	TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.	Through 26 weeks

Eligibility Module

Eligibility Criteria

Inclusion Critera:

Male or female patients' ≥18 years of age who have been diagnosed with Atypical Hemolytic-Uremic Syndrome (aHUS).
Patients must be receiving PT for aHUS and must be observed to receive ≥ 1 PT treatment every two weeks and no more than 3 PT treatments/week (at an unchanged frequency) for at least 8 weeks before first dose of IP.
Platelet Count Pre-PT Baseline Set-Point (collected in the hours before the Qualifying PT Episode) is within 75% of the average of the Pre-PT platelet counts collected at Screening and during the Observation Period.
Known complement regulatory protein genetic abnormality.
Lactate dehydrogenase (LDH) level at screening or at the onset of the current aHUS episode was ≥ ULN. If LDH is normal at screening, other markers indicative of ongoing hemolysis such as haptoglobin, schistocytes should be evaluated and discussed with Sponsor.
Creatinine level ≥ ULN for age.
Female patients of childbearing potential must be practicing an effective, reliable and medically approved contraceptive regimen during the entire duration of the study, including the follow-up period and for up to 5 months following eculizumab treatment discontinuation.
Able to give written informed consent.
Able and willing to comply with study procedures.

Exclusion Criteria:

TTP, (defined as ADAMTS-13 activity <5%) from an historical observation (prior to initiation of plasma therapy) or as tested at the screening visit by the central laboratory.
Malignancy within 5 years of screening.
Typical HUS (Shiga toxin +).
Known HIV infection.
Identified drug exposure-related HUS.
Infection-related HUS.
HUS related to bone marrow transplant.
HUS related to vitamin B12 deficiency.
Patients with a confirmed diagnosis of sepsis.
Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease.
Pregnancy or lactation.
Unresolved meningococcal disease.
Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome.
Any medical or psychological condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study.
Patients who have received previous treatment with eculizumab.
Patients receiving IVIg within 8 weeks or Rituximab therapy within 12 weeks of the screening visit.
Patients receiving other immunosuppressive therapies such as steroids, mTOR inhibitors or tacrolimus are excluded unless: [1] part of an established post-transplant anti-rejection regime, [2] patient has confirmed anti-CFH antibody requiring immunosuppressive therapy, and [3] dose of such medications have been unchanged for at least 4 weeks prior to the screening period and throughout the Observation Period or [4] patient is experiencing an acute aHUS relapse immediately after transplant.
Patients receiving Erythrocyte Stimulating Agents (ESAs) unless already on a stable dose for at least 4 weeks prior to the screening period, or a washout period of at least 2 weeks from the last dose of ESA therapy.
Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures beginning 4 weeks prior to screening and throughout the entire trial.
Hypersensitivity to eculizumab, to murine proteins or to one of the excipients.

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33783815	Derived	Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD012862. doi: 10.1002/14651858.CD012862.pub2.
23738544	Derived	Legendre CM, Licht C, Muus P, Greenbaum LA, Babu S, Bedrosian C, Bingham C, Cohen DJ, Delmas Y, Douglas K, Eitner F, Feldkamp T, Fouque D, Furman RR, Gaber O, Herthelius M, Hourmant M, Karpman D, Lebranchu Y, Mariat C, Menne J, Moulin B, Nurnberger J, Ogawa M, Remuzzi G, Richard T, Sberro-Soussan R, Severino B, Sheerin NS, Trivelli A, Zimmerhackl LB, Goodship T, Loirat C. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013 Jun 6;368(23):2169-81. doi: 10.1056/NEJMoa1208981.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Eculizumab	All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

The intent-to-treat (ITT) population was defined as all patients who received any amount of eculizumab, and were considered evaluable for safety and efficacy analyses. For both the efficacy and safety analyses, all 20 patients who were treated with study drug were included in the ITT population.

Arm/Group Information

ID	Title	Description
BG000	Eculizumab	All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00032.3± 14.92

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00012
Male	BG0008

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Patients With TMA Event-free Status

TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.

The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

Through 26 weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG00020

Title

Denominators

Categories

Title	Measurements
	OG00080(56 to 94)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled. All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.					Percent of TMA event-free responders	80			2-Sided	95	56	94				No	Superiority or Other

Primary

Percentage of Patients With Hematologic Normalization

Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.

Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

Through 26 weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Primary

Percentage of Patients With Complete TMA Response

The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.

Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.

Posted

Number

95% Confidence Interval

Percentage of Participants

Through 26 weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants

Secondary

TMA Intervention Rate

TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.

A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.

Posted

Mean

Standard Deviation

#events/patient/day

Through 26 weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Secondary

Platelet Count Change From Baseline to 26 Weeks

Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.

Posted

Least Squares Mean

95% Confidence Interval

10^9 cells/L

From Baseline to 26 Weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Platelet Count Normalization

Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks

The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

Through 26 Weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With TMA Event-free Status

The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeksend of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

Through End of Study, Median Exposure 156 Weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Hematologic Normalization

Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

Through End of Study, Median Exposure 156 Weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Complete TMA Response

The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.

Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.

Posted

Number

95% Confidence Interval

Percentage of Participants

Through End of Study, Median Exposure 156 Weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants

Secondary

TMA Intervention Rate

TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.

A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.

Posted

Mean

Standard Deviation

#events/patient/day

Through End of Study, Median Exposure 156 Weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants

Secondary

Platelet Count Change From Baseline to 156 Weeks

Posted

Least Squares Mean

95% Confidence Interval

10^9 cells/L

From Baseline to 156 Weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Platelet Count Normalization

Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.

The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.

Posted

Number

95% Confidence Interval

Percentage of Participants

Through End of Study, Median Exposure 156 Weeks

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Secondary

Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration

PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.

Posted

Mean

Standard Deviation

micrograms/mil

Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.

ID	Title	Description
OG000	Eculizumab	eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Eculizumab	All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.			13	20	20	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pericardial effusion	Cardiac disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Medical device complication	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Transplant rejection	Immune system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Amyloidosis	Immune system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Bacteraemia	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Enterococcal infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hepatitis E	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Influenza	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Localised infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Peritonitis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Pneumonia	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Post procedural infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Q fever	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Headache	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Catheter removal	Surgical and medical procedures	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Limb operation	Surgical and medical procedures	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hypotension	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Vein disorder	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Venous thrombosis limb	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abnormal clotting factor	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0007 affected20 at risk
Anaemia folate deficiency	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Microcytosis	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Dermoid cyst	Congenital, familial and genetic disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Ear pain	Ear and labyrinth disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Motion sickness	Ear and labyrinth disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Eye irritation Conjunctival haemorrhage	Eye disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Ocular hyperaemia	Eye disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Conjunctivitis	Eye disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0005 affected20 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Abdominal rigidity	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG00010 affected20 at risk
Flatulence	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Gingival hyperplasia	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Gingival ulceration	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Malaena	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG00010 affected20 at risk
Subileus	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG00010 affected20 at risk
Asthenia	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Chest discomfort	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Chest pain	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Extravasation	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Fatigue	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Hypothermia	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Infusion site extravasation	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Infusion site swelling	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Injection site haematoma	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Localised oedema	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Malaise	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Medical device complication	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Medical device pain	Gastrointestinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Oedema	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Oedema peripheral	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0006 affected20 at risk
Pain	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Polyp	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Pyrexia	General disorders	MedDRA Version 15.1	Systematic Assessment	EG0007 affected20 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hypersensitivity	Immune system disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Seasonal allergy	Immune system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Ateriovenous fistula site infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
BK virus infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Bacteraemia	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Bronchitis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Erythrasma	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Fungal infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Fungal skin infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Herpes zoster	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Influenza	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Localised infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG00012 affected20 at risk
Otitis media	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Pneumonia	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Post procedural infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Sinusitis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0008 affected20 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Vaginal infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Viral pharyngitis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Wound	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Basophil count increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Blood creatine increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Blood creatinine increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Blood parathyroid hormone increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Blood potassium increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Blood pressure abnormal	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Cardiac murmur	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Eosinophil count increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Glomerular filtration rate decreased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Haptoglobin increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Low density lipoprotein increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Monocyte count increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Platelet count decreased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Reticulocyte count increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Weight decreased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
White blood cell count increased	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
White blood cells urine positive	Investigations	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Alkalosis	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0006 affected20 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG00011 affected20 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Angiomyolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Cerebral haematoma	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Cerebral microangiopathy	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Dizziness	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Headache	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG00011 affected20 at risk
Myoclonus	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Paresis	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Somnolence	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Syncope	Nervous system disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Affective disorder	Psychiatric disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Anxiety	Psychiatric disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Depression	Psychiatric disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Insomnia	Psychiatric disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Dysuria	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Pollakiuria	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Renal failure acute	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Breast swelling	Reproductive system and breast disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0007 affected20 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Heat rash	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0003 affected20 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Arterial haemorrhage	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Arterial occlusive disease	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Haematoma	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Haemorrhage	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Hypertension	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0009 affected20 at risk
Hypotension	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0004 affected20 at risk
Orthostatic hypotension	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0002 affected20 at risk
Vein disorder	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk
Venous thrombosis	Vascular disorders	MedDRA Version 15.1	Systematic Assessment	EG0001 affected20 at risk

ID	Term
D065766	Atypical Hemolytic Uremic Syndrome

Ancestor Terms

ID	Term
D006463	Hemolytic-Uremic Syndrome
D014511	Uremia
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D057049	Thrombotic Microangiopathies
D013921	Thrombocytopenia
D001791	Blood Platelet Disorders
D000095542	Cytopenia

ID	Term
C481642	eculizumab

Facility	Status	City	State	ZIP	Country	Contacts
		Toronto			Canada

ID	Type	Description	Link
BB-IND 11075
EudraCT Number 2008-006954-17