Extension Study of Etelcalcetide in the Treatment of Seco... | NCT01785875

NCT01785875

ID	Type	Description	Link
KAI-4169-008	Other Identifier	KAI Pharmaceuticals, Inc (wholly owned subsidiary of Amgen Inc.)
2012-002808-41	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Etelcalcetide	Experimental	Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	Drug: Etelcalcetide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etelcalcetide	Drug	Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)	Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.	From first dose until 30 days after last dose; the treatment period was 52 weeks.
Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4	Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.	52 weeks
Number of Participants Who Developed Anti-etelcalcetide Antibodies	A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.	Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit
Change From Baseline in Blood Pressure	Blood pressure (BP) values were taken post-hemodialysis assessments.	Baseline and Weeks 24 and 48

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase	The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.	Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)

Eligibility Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35211	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
30875390	Background	Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.
30859218	Derived

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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
	BG00058.3± 14.4

Age, Customized

Number

participants

Title

Denominators

Categories

< 65 years

Title	Measurements
	BG000577

≥ 65 years

Title	Measurements
	BG000

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000341
Male	BG000550

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0001

Asian

Title	Measurements
	BG000

Ethnicity

Number

participants

Title

Denominators

Categories

Hispanic/Latino

Title	Measurements
	BG000122

Not Hispanic/Latino

Title	Measurements
	BG000

Parathyroid Hormone (PTH) Level

Number

participants

Title

Denominators

Categories

< 600 pg/mL

Title	Measurements
	BG000405

600 - ≤ 1000 pg/mL

Title	Measurements
	BG000

PTH Concentration

Data available for 854 participants

Mean

Standard Deviation

pg/mL

Title

Denominators

Categories

Title	Measurements
	BG000769.5± 574.4

Corrected Calcium

Data available for 889 participants

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG0009.67± 0.68

Phosphorus

Data available for 887 participants

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG0005.63± 1.75

Corrected Calcium Phosphorus Product (cCa x P)

Data available for 887 participants

Mean

Standard Deviation

mg²/dL²

Title

Denominators

Categories

Title	Measurements
	BG00054.36± 17.17

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

Number of Participants With Adverse Events (AEs)

Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.

All participants who received at least 1 dose of etelcalcetide.

Posted

Number

participants

From first dose until 30 days after last dose; the treatment period was 52 weeks.

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG003	Etelcalcetide Total	Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Units	Counts
Participants	OG000383 OG001384 OG002123 OG003

Title

Denominators

Categories

Any adverse event

Title	Measurements
	OG000354 OG001337 OG002108 OG003

Primary

Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4

Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.

All participants who received at least 1 dose of etelcalcetide.

Posted

Number

participants

52 weeks

ID	Title	Description
OG000	Etelcalcetide Total	Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Units	Counts
Participants	OG000

Primary

Number of Participants Who Developed Anti-etelcalcetide Antibodies

A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.

Participants who received at least 1 dose of etelcalcetide and with a post-baseline antibody result.

Posted

Number

participants

Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002

Secondary

Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase

The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.

Participants with pre-dialysis PTH assessment at baseline and during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12

The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.

Participants with pre-dialysis PTH assessment at baseline and during EAP12

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide

Secondary

Percentage of Participants With PTH ≤ 300 pg/mL During the EAP

Participants with predialysis PTH assessment during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide

Posted

Number

95% Confidence Interval

percentage of participants

Baseline and the efficacy assessment phase

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12

Participants with predialysis PTH assessment during the EAP12

Posted

Number

95% Confidence Interval

percentage of participants

Week 46 to 53

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percent Change From Baseline in Mean PTH During the EAP

Participants with available data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percent Change From Baseline in Mean PTH During the EAP12

Participants with available data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percent Change From Baseline in Mean Corrected Calcium During the EAP

Participants with available data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percent Change From Baseline in Mean Corrected Calcium During the EAP12

Participants with available data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP

Participants with available data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12

Participants with available data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percent Change From Baseline in Mean Phosphorus During the EAP

Participants with available data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Secondary

Percent Change From Baseline in Mean Phosphorus During the EAP12

Participants with available data

Posted

Mean

Standard Error

percent change

Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Primary

Change From Baseline in Blood Pressure

Blood pressure (BP) values were taken post-hemodialysis assessments.

Participants who received at least 1 dose of etelcalcetide and with available data at each time point (indicated by n)

Posted

Mean

Standard Error

mmHg

Baseline and Weeks 24 and 48

ID	Title	Description
OG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
OG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	20120229 / 20120230 Placebo	Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	161	383	289	383
EG001	20120229 / 20120230 Etelcalcetide	Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	142	384	249	384
EG002	20120359 Etelcalcetide	Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	53	123	75	123
EG003	Total	Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.	356	890	613	890

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0011 affected384 at risk EG0022 affected123 at risk EG0036 affected890 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected383 at risk EG0016 affected384 at risk EG0020 affected123 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0013 affected384 at risk EG0022 affected123 at risk EG003
Angina unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Aortic valve disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected383 at risk EG0014 affected384 at risk EG0020 affected123 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0012 affected384 at risk EG0021 affected123 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected383 at risk EG0012 affected384 at risk EG0024 affected123 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0013 affected384 at risk EG0020 affected123 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected383 at risk EG0017 affected384 at risk EG0023 affected123 at risk EG003
Cardiac valve disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0013 affected384 at risk EG0020 affected123 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cardiovascular insufficiency	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0016 affected384 at risk EG0020 affected123 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0014 affected384 at risk EG0021 affected123 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Torsade de pointes	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0012 affected384 at risk EG0022 affected123 at risk EG003
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Goitre	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cataract	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Diplopia	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Lens dislocation	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Optic neuropathy	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0013 affected384 at risk EG0021 affected123 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Anorectal varices haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Gastric disorder	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0022 affected123 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0014 affected384 at risk EG0024 affected123 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Gastrointestinal vascular malformation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Megacolon	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pancreatic duct obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0012 affected384 at risk EG0021 affected123 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Adverse drug reaction	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Asthenia	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0012 affected384 at risk EG0021 affected123 at risk EG003
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0017 affected384 at risk EG0021 affected123 at risk EG003
Device occlusion	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Drug resistance	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Haemorrhagic cyst	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Hyperthermia	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Hyperthermia malignant	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Hypothermia	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Impaired healing	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected383 at risk EG0015 affected384 at risk EG0021 affected123 at risk EG003
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0012 affected384 at risk EG0023 affected123 at risk EG003
Sudden death	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Thrombosis in device	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0022 affected123 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0013 affected384 at risk EG0020 affected123 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Hepatotoxicity	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Abdominal wall abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Abscess limb	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Acinetobacter bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Acinetobacter infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Appendicitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Arteriovenous graft site infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0022 affected123 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Bacterial tracheitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0008 affected383 at risk EG0014 affected384 at risk EG0021 affected123 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Cystitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Device related infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Device related sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Diabetic gangrene	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Endocarditis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Erysipelas	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Escherichia bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Gangrene	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0022 affected123 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0006 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Genital abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Graft infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0011 affected384 at risk EG0022 affected123 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Localised infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0004 affected383 at risk EG0013 affected384 at risk EG0021 affected123 at risk EG003
Osteomyelitis acute	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Peritonitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0007 affected383 at risk EG0015 affected384 at risk EG0023 affected123 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Renal cyst infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00010 affected383 at risk EG0012 affected384 at risk EG0023 affected123 at risk EG003
Septic shock	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0011 affected384 at risk EG0022 affected123 at risk EG003
Shunt infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Skin infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Tracheitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0012 affected384 at risk EG0021 affected123 at risk EG003
Urosepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Viral infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Wound infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Wound sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0007 affected383 at risk EG0016 affected384 at risk EG0020 affected123 at risk EG003
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0014 affected384 at risk EG0021 affected123 at risk EG003
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0004 affected383 at risk EG0016 affected384 at risk EG0020 affected123 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Compression fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Coronary bypass thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Dialysis related complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0021 affected123 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Haemodialysis-induced symptom	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Peripheral arterial reocclusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Shunt thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Splenic injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Stoma site pain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0022 affected123 at risk EG003
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0004 affected383 at risk EG0012 affected384 at risk EG0022 affected123 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Wound complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Anticoagulation drug level below therapeutic	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Blood calcium decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Blood pressure increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Hepatitis C antibody positive	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
International normalised ratio increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Troponin increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0018 affected384 at risk EG0024 affected123 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00014 affected383 at risk EG00110 affected384 at risk EG0025 affected123 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected383 at risk EG0014 affected384 at risk EG0021 affected123 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Bladder adenocarcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Colon cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Ataxia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0013 affected384 at risk EG0021 affected123 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Meralgia paraesthetica	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Migraine	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Presyncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Seizure	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected383 at risk EG0012 affected384 at risk EG0023 affected123 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Tremor	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Delirium	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0021 affected123 at risk EG003
Depression suicidal	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Hallucination, visual	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected383 at risk EG0010 affected384 at risk EG0022 affected123 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Nephrosclerosis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Pelvic haemorrhage	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0013 affected384 at risk EG0021 affected123 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0012 affected384 at risk EG0021 affected123 at risk EG003
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0013 affected384 at risk EG0020 affected123 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0012 affected384 at risk EG0022 affected123 at risk EG003
Henoch-Schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0015 affected384 at risk EG0020 affected123 at risk EG003
Vasculitic rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Arteriovenous graft	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Therapy cessation	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Arterial occlusive disease	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Dry gangrene	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Extremity necrosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Haematoma	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Haemorrhage	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected383 at risk EG0014 affected384 at risk EG0021 affected123 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected383 at risk EG0014 affected384 at risk EG0022 affected123 at risk EG003
Jugular vein thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Malignant hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0012 affected384 at risk EG0020 affected123 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0021 affected123 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0011 affected384 at risk EG0021 affected123 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected383 at risk EG0014 affected384 at risk EG0020 affected123 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003
Steal syndrome	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected383 at risk EG0010 affected384 at risk EG0020 affected123 at risk EG003
Vasculitis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected383 at risk EG0011 affected384 at risk EG0020 affected123 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00022 affected383 at risk EG00112 affected384 at risk EG0023 affected123 at risk EG00337 affected890 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00041 affected383 at risk EG00146 affected384 at risk EG0028 affected123 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00043 affected383 at risk EG00127 affected384 at risk EG00213 affected123 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00040 affected383 at risk EG00137 affected384 at risk EG00211 affected123 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00020 affected383 at risk EG0016 affected384 at risk EG0022 affected123 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00019 affected383 at risk EG00121 affected384 at risk EG0023 affected123 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00020 affected383 at risk EG00114 affected384 at risk EG00220 affected123 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG00022 affected383 at risk EG00127 affected384 at risk EG0028 affected123 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG00022 affected383 at risk EG00114 affected384 at risk EG0026 affected123 at risk EG003
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG00017 affected383 at risk EG0018 affected384 at risk EG0028 affected123 at risk EG003
Blood calcium decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG000226 affected383 at risk EG001129 affected384 at risk EG00230 affected123 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00019 affected383 at risk EG00118 affected384 at risk EG00210 affected123 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00026 affected383 at risk EG00120 affected384 at risk EG0024 affected123 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00036 affected383 at risk EG00133 affected384 at risk EG00210 affected123 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00016 affected383 at risk EG00123 affected384 at risk EG0026 affected123 at risk EG003
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00025 affected383 at risk EG00125 affected384 at risk EG0022 affected123 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected383 at risk EG00110 affected384 at risk EG0027 affected123 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00021 affected383 at risk EG00120 affected384 at risk EG00213 affected123 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00024 affected383 at risk EG00117 affected384 at risk EG0025 affected123 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG00030 affected383 at risk EG00118 affected384 at risk EG00210 affected123 at risk EG003
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG00036 affected383 at risk EG00125 affected384 at risk EG0025 affected123 at risk EG003

ID	Term
D006962	Hyperparathyroidism, Secondary
D051436	Renal Insufficiency, Chronic
D006996	Hypocalcemia

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014883	Water-Electrolyte Imbalance