A Study to Evaluate DCR-PHXC in Children and Adults With... | NCT03847909

NCT03847909

Status Module

Label	Type	Description	Intervention Names
DCR-PHXC	Experimental	Intervention, drug, DCR-PHXC	Drug: DCR-PHXC
Placebo - Sterile Normal Saline (0.9% NaCl)	Placebo Comparator	Placebo, sterile normal saline (0.9% NaCl) for subcutaneous (SC) injection	Drug: Sterile Normal Saline (0.9% NaCl)

Name	Type	Description	Arm Group Labels	Other Names
DCR-PHXC	Drug	Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection	DCR-PHXC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC From Day 90 To Day 180, Based on Percent Change From Baseline in 24-Hour Uox	The AUC of 24-hour urinary oxalate (Uox) from Day 90 to Day 180, based on percent change from baseline, was compared between the active treatment group and placebo group. A multiple imputation approach was used to handle missing Uox data and then calculate the AUC.	From Day 90 to 180

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Whose 24-hour Uox Values Normalized or Near-normalized on at Least 2 Consecutive Visits	Percentage of participants whose 24-hour Uox values normalized or near-normalized on at least 2 consecutive visits are presented. Normalization of Uox was defined as less than (<) 0.46 millimole per 24 hours (mmol/24 hours) and near normalization was defined as greater than or equal to (>=) 0.46 to < 0.60 mmol/24 hours (values adjusted per 1.73 square meter [1.73 m^2] body surface area [BSA] in participants aged <18 years).

Eligibility Module

Name	Affiliation	Role
Clinical Transparency (dept. 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Site		San Francisco	California	94143	United States
Clinical Trial Site

PubMed Identifier	Type	Citation	Retractions
40601241	Derived	Zhang S, Gamallo P, Rawson V. Population Pharmacokinetic and Pharmacodynamic Modelling and Simulation for Nedosiran Clinical Development and Dose Guidance in Pediatric Patients with Primary Hyperoxaluria Type 1. Clin Pharmacokinet. 2025 Sep;64(9):1395-1411. doi: 10.1007/s40262-025-01540-1. Epub 2025 Jul 2.
40193200	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DCR-PHXC	Participants aged greater than or equal to (>=) 12 years weighing >=50 kilograms (kg) received nedosiran 170 milligram (mg) (160 milligrams per millilitre [mg/mL] free acid equivalent [FAE]); participants >=12 years weighing less than (<) 50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 milligrams per kilogram (mg/kg) (3.3 mg/kg FAE) not exceeding 136 mg, subcutaneous (SC) injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 13, 2020	Mar 13, 2024

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

AUC From Day 90 To Day 180, Based on Percent Change From Baseline in 24-Hour Uox

The AUC of 24-hour urinary oxalate (Uox) from Day 90 to Day 180, based on percent change from baseline, was compared between the active treatment group and placebo group. A multiple imputation approach was used to handle missing Uox data and then calculate the AUC.

MITT population included all participants in the ITT population who had at least one efficacy assessment after the Day 90 dosing visit, where the ITT population included all participants who were randomized and had at least one post-baseline efficacy assessment.

Posted

Least Squares Mean

Standard Error

Percent change in 24-hour Uox AUC

From Day 90 to 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg free acid equivalent [FAE]) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants	OG00022 OG00112

Title

Denominators

Categories

Title	Measurements
	OG0003507.4± 788.49 OG001-1664.4± 1189.96

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		<0.0001		Difference of Least Mean Square	5171.7	Standard Error of the Mean	1144.07	2-Sided	95	2929.3	7414.2					Superiority	P value is from an ANCOVA model with treatment group as the main effect, age category, baseline eGFR category, baseline Uox value as covariates for adjustment.

Secondary

Percentage of Participants Whose 24-hour Uox Values Normalized or Near-normalized on at Least 2 Consecutive Visits

Percentage of participants whose 24-hour Uox values normalized or near-normalized on at least 2 consecutive visits are presented. Normalization of Uox was defined as less than (<) 0.46 millimole per 24 hours (mmol/24 hours) and near normalization was defined as greater than or equal to (>=) 0.46 to < 0.60 mmol/24 hours (values adjusted per 1.73 square meter [1.73 m^2] body surface area [BSA] in participants aged <18 years).

Modified Intent-to-treat population (MITT) included all participants in the intent-to-treat (ITT) population who had at least one efficacy assessment after the Day 90 dosing visit where ITT population included all participants who were randomized and had at least one post-baseline efficacy assessment.

Posted

Number

Percentage of participants

From Day 90 to 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Secondary

Percent Change From Baseline to Day 180 in the Summed Surface Area of Kidney Stones

Percent change from baseline to Day 180 in the summed surface area measured in millimetre square (mm^2) of kidney stones is presented.

The ITT population included all participants who were randomised and had at least one post-baseline efficacy assessment. Number of participants analysed signifies participants with available data.

Posted

Median

Full Range

Percent change in summed surface area

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 180 in the Number of Kidney Stones

Percent change from baseline to Day 180 in the number of kidney stones is presented.

The ITT population included all participants who were randomised and had at least one post-baseline efficacy assessment. Number of participants analysed signifies participants with available data.

Posted

Median

Full Range

Percent change in kidney stone numbers

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Percent Change From Baseline to Day 180 in Plasma Oxalate (For Adults Only)

Percent change from baseline to Day 180 in plasma oxalate (for adults only) is presented.

Analysis population included all adult participants from ITT population who were randomised and had at least one post-baseline efficacy assessment. Number of participants analysed signifies participants with available data.

Posted

Median

Full Range

Percent change in plasma oxalate

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Rate of Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to Day 180

Monthly rate of eGFR change is presented. eGFR was calculated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and creatinine-based equation.

The ITT population included all participants who were randomised and had at least one post-baseline efficacy assessment.

Posted

Mean

Standard Error

mL/minute/1.73 m^2

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Number of Treatment Emergent Adverse Events (TEAEs) And Serious Treatment Emergent Adverse Events (TEAEs)

Number of TEAEs and TESAEs are presented. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalisation, results in persistent disability/incapacity or is a congenital anomaly/birth defect. TEAE was defined as any AE with an onset date/time on or after administration (including any partial administration) of the first dose of study intervention and through the study completion date from the end of study case report form (CRF).

The safety population included all participants randomly assigned to study intervention and who took at least 1 partial or full dose of study intervention.

Posted

Number

Events

From Baseline up to Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo

Secondary

Change From Baseline in Electrocardiogram (ECG): Heart Rate

Change from baseline in heart rate is presented.

The safety population included all participants randomly assigned to study intervention and who took at least 1 partial or full dose of study intervention. Number of participants analysed signifies participants with available data.

Posted

Mean

Standard Deviation

beats per minute (beats/min)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in ECG: PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval

Change from baseline in PR interval, QRS duration, QT interval, QTcB interval, QTcF interval and RR interval is presented.

Posted

Mean

Standard Deviation

milliseconds (msec)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Number of Participants With Most Abnormal Post-Baseline Shift in Physical Examination

Number of participants who had most abnormal post-baseline shift in physical examination are presented. Physical examination shifts were categories into 4 categories: 1) missing; 2) normal; 3) abnormal-not clinically significant (NCS) and 4) abnormal-clinically significant (CS). Each category was presented according body systems including: 1) eyes, ears, nose and throat; 2) chest/respiratory; 3) heart/cardiovascular; 4) gastrointestinal/liver; 5) musculoskeletal/extremities; 6) dermatological/skin; 7) thyroid/neck; 8) lymph nodes; 9) neurological.

The safety population included all participants randomly assigned to study intervention and who took at least 1 partial or full dose of study intervention.

Posted

Count of Participants

Participants

Baseline up to Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Secondary

Change From Baseline in Vital Signs: Height

Change from baseline to Day 180 in height is presented.

Posted

Mean

Standard Deviation

centimetres (cm)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Vital Signs: Weight

Change from baseline to Day 180 in weight is presented.

Posted

Mean

Standard Deviation

kilograms

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Vital Signs: Body Mass Index (BMI)

Change from baseline to Day 180 in BMI is presented.

Posted

Mean

Standard Deviation

Kilograms per square meter (kg/m^2)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Vital Signs: Oral Body Temperature

Change from baseline to Day 180 in oral body temperature is presented.

Posted

Mean

Standard Deviation

Degree Celsius (C)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Vital Signs: Heart Rate

Change from baseline to Day 180 in heart rate is presented.

Posted

Mean

Standard Deviation

beats/minute

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Vital Signs: Respiratory Rate

Change from baseline to Day 180 in respiratory rate is presented.

Posted

Mean

Standard Deviation

Breaths per minute

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure

Change from baseline to Day 180 in systolic and diastolic blood pressure is presented.

Posted

Mean

Standard Deviation

millimetres of mercury (mmHg)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Chemistry Laboratory Tests: Alanine Aminotransferase, Aspartate Aminotransferase, Glutamate Dehydrogenase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Lactate Dehydrogenase and Creatine Kinase

Change from baseline to Day 180 in alanine aminotransferase, aspartate aminotransferase, glutamate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, lactate dehydrogenase and creatine kinase are presented.

Posted

Mean

Standard Deviation

Units per litre (U/L)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Secondary

Change From Baseline in Clinical Chemistry Laboratory Tests: Bilirubin, Direct Bilirubin and Creatinine

Change from baseline to Day 180 in bilirubin, direct bilirubin and creatinine are presented.

Posted

Mean

Standard Deviation

micromoles per litre (umol/L)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts

Secondary

Change From Baseline in Clinical Chemistry Laboratory Tests: Protein, Albumin

Change from baseline to Day 180 in protein and albumin are presented.

Posted

Mean

Standard Deviation

grams per litre (g/L)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Chemistry Laboratory Tests: Sodium, Chloride, Potassium and Urea

Change from baseline to Day 180 in sodium, chloride, potassium and urea are presented.

Posted

Mean

Standard Deviation

millimoles per litre (mmol/L)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts

Secondary

Change From Baseline in Clinical Chemistry Laboratory Tests: Vitamin B6

Change from baseline to Day 180 in vitamin B6 is presented.

Posted

Mean

Standard Deviation

nanomoles per litre (nmol/L)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes

Change from baseline to Day 180 in erythrocytes is presented.

Posted

Mean

Standard Deviation

10^12 cells per liter

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration

Change from baseline to Day 180 in hemoglobin and erythrocytes mean corpuscular hemoglobin concentration are presented.

Posted

Mean

Standard Deviation

gram per litre (g/L)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Hematocrit

Change from baseline to Day 180 in hematocrit is presented.

Posted

Mean

Standard Deviation

Litre/litre (L/L)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes (Ery.) Mean Corpuscular Volume and Mean Platelet Volume

Change from baseline to Day 180 in ery. mean corpuscular volume and mean platelet volume are presented.

Posted

Mean

Standard Deviation

femtoliter (fL)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Erythrocytes Mean Corpuscular Hemoglobin

Change from baseline to Day 180 in erythrocytes mean corpuscular hemoglobin is presented.

Posted

Mean

Standard Deviation

picogram (pg)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Reticulocytes, Platelets, Leukocytes, Lymphocytes, Monocytes, Eosinophils, Basophils, Neutrophils

Change from baseline to Day 180 in reticulocytes, platelets, leukocytes, lymphocytes, monocytes, eosinophils, basophils, neutrophils are presented.

Posted

Mean

Standard Deviation

10^12 cells per liter

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Lymphocytes/Leukocytes

Change from baseline to Day 180 in lymphocytes/leukocytes is presented.

Posted

Mean

Standard Deviation

Percentage of lymphocytes/leukocytes

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Monocytes/Leukocytes

Change from baseline to Day 180 in monocytes/leukocytes is presented.

Posted

Mean

Standard Deviation

Percentage of monocytes/leukocytes

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Eosinophils/Leukocyte

Change from baseline to Day 180 in eosinophils/leukocytes is presented.

Posted

Mean

Standard Deviation

Percentage of eosinophils/leukocytes

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Basophils/Leukocytes

Change from baseline to Day 180 in basophils/leukocytes is presented.

Posted

Mean

Standard Deviation

Percentage of basophils/leukocytes

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Hematology Laboratory Tests: Neutrophils/Leukocytes

Change from baseline to Day 180 in neutrophils/leukocytes is presented.

Posted

Mean

Standard Deviation

Percentage of neutrophils/leukocytes

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Urinalysis Laboratory Tests: Specific Gravity

Change from baseline to Day 180 in urine specific gravity is presented.

Posted

Mean

Standard Deviation

gram per millilitre (g/mL)

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Change From Baseline in Clinical Urinalysis Laboratory Tests: pH

Change from baseline to Day 180 in urine pH is presented.

Posted

Mean

Standard Deviation

Baseline, Day 180

ID	Title	Description
OG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
OG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.

Units	Counts
Participants

Secondary

Maximum Observed Plasma Concentration (Cmax) of DCR-PHXC

The Cmax was defined as the maximum observed plasma concentration during a dosing interval. Data for this endpoint is reported only for adults and adolescent participants from PK population.

The Pharmacokinetic (PK) population included all participants in the safety population without major dosing violations, where safety population included all participants randomly assigned to study intervention and who took at least 1 partial or full dose of study intervention. Number of participants analysed signifies participants with available data and number analysed signifies participants with available data for each specified category.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per millilitre (ng/mL)

For adults: Day 1 and 30: predose, 5, 15, and 30 minutes and 1, 2, 4, 6, 10, and 12 hours (hrs) postdose; Day 150: predose, 2, 6, and 12 hours postdose For adolescents: Days 1 and 30: predose, 30 minutes and 2 and 10 hours postdose

ID	Title	Description
OG000	DCR-PHXC: Adults	Participant analysis set included all adult participant (age >= 18 years) from DCR-PHXC arm who received 170 mg nedosiran.
OG001	DCR-PHXC: Adolescents	Participants analysis set included all adolescents (aged 12-17 years) from DCR-PHXC arm who received 170 mg nedosiran.

Secondary

Area Under the Curve From Time of Administration to the Last Measurable Concentration (AUC0-last) of of DCR-PHXC

AUC0-last was defined as the area under the curve from time of administration to the last measurable concentration. Data for this endpoint is reported only for adults and adolescent participants from PK population.

The PK population included all participants in the safety population without major dosing violations, where safety population included all participants randomly assigned to study intervention and who took at least 1 partial or full dose of study intervention. Number of participants analysed signifies participants with available data and number analysed signifies participants with available data for each specified category.

Posted

Geometric Mean

Geometric Coefficient of Variation

hours*nanograms per millilitre (h*ng/mL)

For adults: Day 1 and 30: predose, 5, 15, and 30 minutes and 1, 2, 4, 6, 10, and 12 hours postdose; Day 150: predose, 2, 6, and 12 hours postdose For adolescents: Days 1 and 30: predose, 30 minutes and 2 and 10 hours postdose

ID	Title	Description
OG000	DCR-PHXC: Adults	Participant analysis set included all adult participant (age >= 18 years) from DCR-PHXC arm who received 170 mg nedosiran.
OG001	DCR-PHXC: Adolescents	Participants analysis set included all adolescents (aged 12-17 years) from DCR-PHXC arm who received 170 mg nedosiran.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site erythema	General disorders	MedDRA 23.1	Systematic Assessment	EG0005 affected23 at risk EG0010 affected12 at risk
Injection site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected12 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected23 at risk EG0012 affected12 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected12 at risk
Menstrual disorder	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected12 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Depression	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Neutrophil count decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected12 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected12 at risk
Alanine aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Glutamate dehydrogenase increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Adverse event following immunisation	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected23 at risk EG0013 affected12 at risk
Sensory disturbance	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0004 affected23 at risk EG0011 affected12 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected23 at risk EG0010 affected12 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected12 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected23 at risk EG0012 affected12 at risk
Renal colic	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected12 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 affected23 at risk EG0011 affected12 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected12 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected12 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0012 affected12 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 affected23 at risk EG0011 affected12 at risk
COVID-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Rhinitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk

ID	Term
C536414	Primary hyperoxaluria type 1
C536415	Primary hyperoxaluria type 2
D007674	Kidney Diseases
D014570	Urologic Diseases
D030342	Genetic Diseases, Inborn
D006960	Hyperoxaluria, Primary

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006959	Hyperoxaluria
D002239	Carbohydrate Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Title	Description
BG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
BG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DCR-PHXC	Participants aged >=12 years weighing >=50 kg received nedosiran 170 mg (160 mg/mL FAE); participants >=12 years weighing <50 kg received 136 mg (128 mg FAE); and participants 6-11 years received 3.5 mg/kg (3.3 mg/kg FAE) not exceeding 136 mg, SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.	0	23	1	23	16	23
EG001	Placebo	Participants received the equivalent volume of nedosiran matching placebo SC injection into the abdomen or thigh on Days 1, 30, 60, 90, 120 and 150.	0	12	2	12	10	12

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 affected23 at risk EG0010 affected12 at risk
Blood creatinine increased	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk
Renal colic	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 affected23 at risk EG0011 affected12 at risk