An Efficacy and Safety Study of Sevelamer Carbonate in Hy... | NCT01574326

ID	Type	Description	Link
2011-002329-23	EudraCT Number
DRI12793	Other Identifier	Genzyme Corporation

Status Module

Label	Type	Description	Intervention Names
FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate	Placebo Comparator	Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).	Drug: Placebo Drug: Sevelamer carbonate
FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate	Experimental	Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.	Drug: Placebo Drug: Sevelamer carbonate

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets	FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline (Week 0) to Week 2 in Serum Phosphorus	Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.	Baseline, Week 2
Treatment - Emergent Adverse Events (AEs)	A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.	Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus	Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.	Baseline, Week 28/Early Termination

Eligibility Module

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 8003		Birmingham	Alabama	35205	United States
Investigational Site Number 8005

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate	Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate 3 times a day (TID) for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as powder for oral suspension (POS) & 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate	Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate TID for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 POS and 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
BG001	FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
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

Change From Baseline (Week 0) to Week 2 in Serum Phosphorus

Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.

FAS-FDP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline assessment after the first dose of study drug and on or before Week 2. Three participants (1 in sevelamer carbonate group and 2 in placebo group) were excluded from FAS-FDP due to no baseline phosphorus value at week 2.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 2

ID	Title	Description
OG000	FDP-Placebo for Sevelamer Carbonate	Participants received placebo for sevelamer carbonate for first 2 weeks in FDP.
OG001	FDP-Sevelamer Carbonate	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP.

Units	Counts
Participants	OG00049 OG00148

Title

Denominators

Categories

At Baseline

Title	Measurements
	OG0007.2± 1.841 OG0017.2± 2.09

At Week 2

Title	Measurements
	OG000

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	Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.	ANCOVA	Threshold for significance ≤ 0.05.	0.001		Least square (LS) mean difference	-0.9			2-Sided	95	-1.44	-0.37				No	Superiority or Other

Primary

Treatment - Emergent Adverse Events (AEs)

A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.

Analysis was performed on safety set, which included all enrolled participants who received at least 1 dose of study drug. Participants were analyzed according to actual received treatment.

Posted

Number

participants

Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)

ID	Title	Description
OG000	FDP- Placebo for Sevelamer Carbonate; DTP- Sevelamer Carbonate	Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter, participants received sevelamer carbonate for 26 weeks in DTP.
OG001	FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP based on the screening BSA category.

Secondary

Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus

Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.

FAS-DTP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline phosphorus assessment after Week 2. Five participants (3 in sevelamer carbonate group and 2 in the placebo group) were excluded from the FAS-DTP due to no baseline phosphorus value or no phosphorus assessment after Week 2.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 28/Early Termination

ID	Title	Description
OG000	FDP- Placebo for Sevelamer Carbonate; DTP- Sevelamer Carbonate	Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter participants received sevelamer carbonate for 26 weeks in DTP.
OG001	FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected100 at risk
Abdominal pain	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0023 affected100 at risk
Constipation	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected100 at risk
Diarrhoea	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Gastritis	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Vomiting	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Device dislocation	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Device malfunction	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected100 at risk
Device occlusion	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0021 affected100 at risk
Extravasation	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Fatigue	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Non-cardiac chest pain	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Pyrexia	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0023 affected100 at risk
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Kidney transplant rejection	Immune system disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Bacteraemia	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected100 at risk
Catheter site infection	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Fungal peritonitis	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Gastroenteritis viral	Infections and infestations	MedDra 18	Systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected100 at risk
Pelvic inflammatory disease	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Peritonitis	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0022 affected100 at risk
Peritonitis bacterial	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Pharyngitis	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Pneumonia	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Septic shock	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Upper respiratory tract infection	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected100 at risk
Urinary tract infection	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected100 at risk
Urosepsis	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Vaginitis chlamydial	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Varicella zoster virus infection	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Viral infection	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Laceration	Injury, poisoning and procedural complications	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Post procedural constipation	Injury, poisoning and procedural complications	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Shunt occlusion	Injury, poisoning and procedural complications	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Blood creatinine increased	Investigations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Fluid overload	Metabolism and nutrition disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0022 affected100 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected100 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Mental status changes	Psychiatric disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Oliguria	Renal and urinary disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Renal failure	Renal and urinary disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Renal impairment	Renal and urinary disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Hypertension	Vascular disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0012 affected49 at risk EG0021 affected100 at risk
Hypertensive crisis	Vascular disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Hypotension	Vascular disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected100 at risk
Orthostatic hypotension	Vascular disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk
Vena cava thrombosis	Vascular disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected100 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG00213 affected100 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0002 affected51 at risk EG0010 affected49 at risk EG0029 affected100 at risk
Diarrhoea	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0028 affected100 at risk
Nausea	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0002 affected51 at risk EG0010 affected49 at risk EG00215 affected100 at risk
Vomiting	Gastrointestinal disorders	MedDra 18	Systematic Assessment	EG0003 affected51 at risk EG0010 affected49 at risk EG00219 affected100 at risk
Catheter site pain	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0026 affected100 at risk
Pyrexia	General disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG00216 affected100 at risk
Seasonal allergy	Immune system disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0026 affected100 at risk
Nasopharyngitis	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0026 affected100 at risk
Upper respiratory tract infection	Infections and infestations	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG00210 affected100 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0028 affected100 at risk
Dizziness	Nervous system disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0027 affected100 at risk
Headache	Nervous system disorders	MedDra 18	Systematic Assessment	EG0002 affected51 at risk EG0012 affected49 at risk EG00217 affected100 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0027 affected100 at risk
Hypertension	Vascular disorders	MedDra 18	Systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0027 affected100 at risk
Hypotension	Vascular disorders	MedDra 18	Systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0028 affected100 at risk

ID	Term
D054559	Hyperphosphatemia
D051436	Renal Insufficiency, Chronic

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic 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

ID	Term
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FDP - Placebo	Participants exposed to placebo (for sevelamer carbonate) for first 2 weeks in FDP (median exposure of 15 days).	1	51	6	51
EG001	FDP - Sevelamer Carbonate	Participants exposed to sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for first 2 weeks in FDP (median exposure of 15 days).	4	49	7	49
EG002	DTP - Sevelamer Carbonate	Participants who received placebo and participants who received sevelamer carbonate in FDP received sevelamer carbonate for 26 weeks in DTP (median exposure of 183.5 days in participants who were on sevelamer carbonate in FDP and 183 days in participants who were on placebo in FDP).	31	100	57	100