Study to Evaluate Safety of Vitamin D Receptor Activators... | NCT01134315

Name	Class
North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)	UNKNOWN

Label	Type	Description	Intervention Names
Paricalcitol		Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.	Drug: Paricalcitol
Calcitriol		Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.	Drug: Calcitriol

Name	Type	Description	Arm Group Labels	Other Names
Paricalcitol	Drug		Paricalcitol	ABT-358 Zemplar
Calcitriol

Measure	Description	Time Frame
Percentage of Participants With at Least One Incidence of Hypercalcemia	Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.	Monitored from time of informed consent through end of study + 30 days (total of 745 days).

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs	AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.

Name	Affiliation	Role
Ann Eldred, MD	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 37082		Birmingham	Alabama	35255	United States
Site Reference ID/Investigator# 26762

Label	URL
Related Info	View source

ID	Title	Description
FG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
FG001	Calcitriol

ID	Title	Description
BG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
BG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With at Least One Incidence of Hypercalcemia

Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.

All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]).

Posted

Number

percentage of participants

Monitored from time of informed consent through end of study + 30 days (total of 745 days).

ID	Title	Description
OG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
OG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Units	Counts
Participants	OG00019 OG00137

Title

Denominators

Categories

Overall population (n=19, 37)

Title	Measurements
	OG00036.8 OG00154.1

Participants <3 months in study (n=2, 5)

Title	Measurements
	OG000

Secondary

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs

AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.

All participants

Posted

Number

participants

Monitored from time of informed consent through end of study + 30 days (total of 745 days).

ID	Title	Description
OG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
OG001	Calcitriol

Secondary

Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)

Normal ranges for these chemistry measurements varied according to the age of the participant.

All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.

Posted

Mean

Standard Deviation

mEq/L

Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

ID	Title	Description
OG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
OG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Units	Counts
Participants

Secondary

Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)

Normal ranges for these chemistry measurements varied according to the age of the participant.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

ID	Title	Description
OG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
OG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Units	Counts
Participants

Secondary

Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)

Normal ranges for these chemistry measurements varied according to the age of the participant.

All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.

Posted

Mean

Standard Deviation

ng/mL

Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

ID	Title	Description
OG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
OG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Units	Counts
Participants

Secondary

Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)

Normal ranges for these chemistry measurements varied according to the age of the participant.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

ID	Title	Description
OG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
OG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Units	Counts
Participants

Secondary

Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)

Normal ranges for these chemistry measurements varied according to the age of the participant.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

ID	Title	Description
OG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
OG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Units	Counts
Participants

Secondary

Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)

Normal ranges for these chemistry measurements varied according to the age of the participant.

Posted

Mean

Standard Deviation

g/dL

Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

ID	Title	Description
OG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
OG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Middle Ear Effusion	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Adrenocortical Insufficiency Acute	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Umbilical Hernia, Obstructive	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Catheter Site Erosion	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected40 at risk
Device Dislocation	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Device Leakage	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Device Malfunction	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Medical Device Complication	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Pyrexia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0013 affected40 at risk
Bronchiolitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Catheter Site Cellulitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Cellulitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Device Related Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Fungal Peritonitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Meningitis Aseptic	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Otitis Media	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Peritonitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0004 affected21 at risk EG0018 affected40 at risk
Peritonitis Bacterial	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Pneumonia Primary Atypical	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Pseudomonas Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Respiratory Syncytial Virus Bronchiolitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Septic Shock	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected40 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Viral Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Peritoneal Dialysis Complication	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Blood Urea Nitrogen/Creatinine Ratio Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Weight Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected40 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Renal Osteodystrophy	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Convulsion	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected40 at risk
Hypertensive Encephalopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Seizure Anoxic	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Eating Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected40 at risk
Hypertensive Emergency	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Wegener's Granulomatosis	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Tachycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Deafness Neurosensory	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Middle Ear Effusion	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Tympanic Membrane Perforation	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Visual Impairment	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected40 at risk
Abdominal Mass	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0014 affected40 at risk
Bloody Peritoneal Effluent	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0014 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0015 affected40 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Lip Swelling	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0015 affected40 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Retching	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0014 affected40 at risk
Asthenia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Catheter Site Discharge	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Catheter Site Erythema	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Catheter Site Haemorrhage	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Catheter Site Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Catheter Site Related Reaction	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Device Damage	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Device Malfunction	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Fatigue	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Oedema Peripheral	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected40 at risk
Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Pyrexia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0014 affected40 at risk
Seasonal Allergy	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Candida Nappy Rash	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Catheter Site Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0013 affected40 at risk
Cellulitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected40 at risk
Chronic Sinusitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Clostridial Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Conjunctivitis Infective	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Device Related Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0011 affected40 at risk
Ear Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0013 affected40 at risk
Eye Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Fungal Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Graft Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Oral Herpes	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Otitis Media	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Peritonitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0013 affected40 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0003 affected21 at risk EG0012 affected40 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Pseudomonas Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Serratia Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Stitch Abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Tonsillitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0003 affected21 at risk EG0015 affected40 at risk
Wound Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected40 at risk
Arteriovenous Fistula Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Feeding Tube Complication	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Blood Cortisol Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Blood Glucose Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Blood Parathyroid Hormone Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Blood Phosphorus Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Blood Phosphorus Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Blood Pressure Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Haemoglobin Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Heart Rate Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Occult Blood Positive	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected40 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0010 affected40 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0013 affected40 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected40 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected40 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Renal Osteodystrophy	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected40 at risk
Lethargy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Migraine	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Anxiety	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Listless	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Menstrual Disorder	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 affected21 at risk EG0012 affected40 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Increased Viscosity Of Bronchial Secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0011 affected40 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0012 affected40 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 affected21 at risk EG0012 affected40 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0011 affected40 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0010 affected40 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 affected21 at risk EG0013 affected40 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 affected21 at risk EG0012 affected40 at risk

ID	Term
D006962	Hyperparathyroidism, Secondary
D007676	Kidney Failure, Chronic

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D051436	Renal Insufficiency, Chronic
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

ID	Term
D004100	Dihydroxycholecalciferols
D006887	Hydroxycholecalciferols
D002762	Cholecalciferol
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013261	Sterols
D014807	Vitamin D
D012632	Secosteroids
D008563	Membrane Lipids
D008055	Lipids

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Paricalcitol	Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.			8	21	15	21
EG001	Calcitriol	Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.			26	40	29	40