Clinical Trial to Evaluate Safety and Efficacy of CCX168... | NCT02222155

ID	Type	Description	Link
#FD-R-5414	Other Identifier	Orphan Products Development Grant

Label	Type	Description	Intervention Names
CCX168 low dose plus standard of care	Active Comparator	Capsule, 10 mg, twice daily + standard of care for 12 weeks	Drug: CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids
CCX168 high dose plus standard of care	Active Comparator	Capsule, 30 mg, twice daily + standard of care for 12 weeks	Drug: CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids
Placebo, twice daily + standard of care	Placebo Comparator	Capsule, placebo, twice daily + standard of care for 12 weeks	Other: Placebo, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids

Name	Type	Description	Arm Group Labels	Other Names
CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids	Drug		CCX168 low dose plus standard of care
CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids

Measure	Description	Time Frame
Incidence of Adverse Events	This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms.	Baseline to Day 85
Proportion of Patients Achieving Disease Response Based on BVAS at Day 85	Proportion of Patients achieving 50% reduction in the Birmingham Vasculitis Activity Score [BVAS] at Day 85 and no worsening in any body system component at day 85	Day 85

Measure	Description	Time Frame
Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.	Proportion of subjects achieving disease remission based on Birmingham Vasculitis Activity Score (BVAS) defined as 0 at Day 85.	Day 85
Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85.

Name	Affiliation	Role
MD	Amgen	Study Director

PubMed Identifier	Type	Citation	Retractions
33128347	Derived	Merkel PA, Niles J, Jimenez R, Spiera RF, Rovin BH, Bomback A, Pagnoux C, Potarca A, Schall TJ, Bekker P; CLASSIC Investigators. Adjunctive Treatment With Avacopan, an Oral C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. ACR Open Rheumatol. 2020 Nov;2(11):662-671. doi: 10.1002/acr2.11185. Epub 2020 Oct 31.

ID	Title	Description
FG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
FG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 19, 2016	Jun 9, 2023

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

Incidence of Adverse Events

This is a safety study to assess the overall rates of treatment-emergent adverse events (TEAEs) across all study arms.

Safety population: The Safety Population included all subjects who were randomized and received at least 1 dose of study drug

Posted

Count of Participants

Participants

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts
Participants	OG00013 OG00113 OG00216

Title

Denominators

Categories

Title	Measurements
	OG00013 OG00111 OG00215

Primary

Proportion of Patients Achieving Disease Response Based on BVAS at Day 85

Proportion of Patients achieving 50% reduction in the Birmingham Vasculitis Activity Score [BVAS] at Day 85 and no worsening in any body system component at day 85

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.

Posted

Number

proportion of participants

Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts

Secondary

Proportion of Subjects Achieving Disease Remission Based on BVAS at Day 85.

Proportion of subjects achieving disease remission based on Birmingham Vasculitis Activity Score (BVAS) defined as 0 at Day 85.

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.

Posted

Number

proportion of participants

Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts

Secondary

Proportion of Subjects Achieving Early Disease Remission Based on BVAS of 0 at Days 29 and 85.

Proportion of subjects achieving early disease remission based on Birmingham Vasculitis Activity Score (BVAS) score of 0 at Days 29 and 85.

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.

Posted

Number

proportion of participants

Day 29 and 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts

Secondary

Percent Change From Baseline to Day 85 in BVAS.

The Birmingham Vasculitis Activity (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health.

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.

Posted

Mean

Standard Deviation

percentage change from baseline

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Secondary

Proportion of Subjects With Hematuria and Albuminuria at Baseline Who Showed a Renal Response at Day 85

Renal responses among patients (who had hematuria or albuminuria at baseline determined secondary to ANCA-associated vasculitis) were defined as improvement in the following parameters of renal vasculitis: (1) increase from baseline to day 85 in eGFR [Modification of Diet in Renal Disease (MDRD equation)], (2) decrease from baseline to day 85 in hematuria (microscopic count of urinary red blood cells [RBC]), and (3) decrease from baseline to day 85 in albuminuria (first morning urinary albumin:creatinine ratio).

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.

Posted

Number

proportion of participants

Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Secondary

Change in Estimated Glomerular Filtration Rate at Day 85

Mean Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula, for patients with renal disease at baseline.

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.

Posted

Mean

Standard Deviation

ml/min/1.73 m^2

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts

Secondary

Percentage Change in Estimated Glomerular Filtration Rate at Day 85

Mean Percentage Change in Estimated Glomerular Filtration Rate based on modification of diet in renal disease formula.

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.

Posted

Mean

Standard Deviation

% change from baseline (ml/min/1.73 m²)

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts

Secondary

Percent Change of Urinary Red Blood Cells in Patient With Hematuria From Baseline to Day 85

Mean Percent Change of Urinary Red Blood Cells (UBC) in Patients in Hematuria at Baseline.

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.

Posted

Mean

Full Range

percentage change from baseline

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts

Secondary

Percent Change of Urinary Albumin:Creatinine Ratio in Patients With Albuminuria From Baseline to Day 85

Mean Percent Change of Urinary Albumin:Creatinine Ratio in Patients with Albuminuria at Baseline

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.

Posted

Mean

Full Range

percentage change from baseline

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts

Secondary

Percent Change of Urinary MCP-1:Creatinine Ratio From Baseline to Day 85

Mean Percent Change of Urinary monocyte chemoattractant protein (MCP-1:creatinine) ratio from Baseline

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on-treatment BVAS measurement.

Posted

Mean

Full Range

percentage change from baseline

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts

Secondary

Change From Baseline to Day 85 in the VDI

The Vasculitis Damage Index (VDI) is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health)

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 post-baseline, on treatment BVAS measurement.

Posted

Mean

Standard Deviation

score on a scale

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Secondary

Change From Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the SF-36v2

Change from Baseline to Day 85 in Health-Related Quality-Of-Life as Measured by the Short Form-36 (SF-36v2) SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.

*p<0.05 for CCX168 compared to control for change or percent change from baseline.

Posted

Least Squares Mean

Standard Error

score on a scale

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care

Secondary

Mean Change From Baseline to Day 85 in Health-related Quality-of-life as Measured by the EQ-5D-5L

Mean Change from baseline to Day 85 in health-related quality-of-life as measured by the Euro Quality-of-Life-5 Domains-5 Levels (EQ-5D-5L).

EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.

Posted

Mean

Standard Deviation

score on scale

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Secondary

Proportion of Subjects Requiring Rescue Glucocorticoid Treatment From Baseline to Day 85

Proportion of subjects requiring rescue glucocorticoid treatment from Baseline to Day 85

ITT population: The ITT Population included all subjects who were randomized, received at least 1 dose of study medication, and had at least 1 postbaseline, on-treatment BVAS measurement.

Posted

Number

proportion of participants

Baseline to Day 85

ID	Title	Description
OG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
OG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Oedema peripheral	General disorders	Systematic Assessment	EG0001 affected13 at risk EG0012 affected13 at risk EG0024 affected16 at risk
Fatigue	General disorders	Systematic Assessment	EG0003 affected13 at risk EG0012 affected13 at risk EG0021 affected16 at risk
Pain	General disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Vessel puncture site bruise	General disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Vessel puncture site haematoma	General disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0022 affected16 at risk
Acne	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Dry gangrene	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Psoriasis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Scab	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected13 at risk EG0012 affected13 at risk EG0022 affected16 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected16 at risk
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected16 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0004 affected13 at risk EG0013 affected13 at risk EG0024 affected16 at risk
Hot flush	Vascular disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Extremity necrosis	Vascular disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Gangrene	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Herpes zoster	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Blood creatinine increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected16 at risk
Amylase increased	Investigations	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Lipase increased	Investigations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Transaminases increased	Investigations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Weight increased	Investigations	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected16 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0022 affected16 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0023 affected16 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Bursitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0023 affected16 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0002 affected13 at risk EG0011 affected13 at risk EG0022 affected16 at risk
Lumbar radiculopathy	Nervous system disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Sinus headache	Nervous system disorders	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Tremor	Nervous system disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Infusion related reaction	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected13 at risk EG0012 affected13 at risk EG0021 affected16 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected13 at risk EG0011 affected13 at risk EG0022 affected16 at risk
Pubis fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Skin injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0022 affected16 at risk
Confusional state	Psychiatric disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0022 affected16 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Nasal ulcer	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0022 affected16 at risk
Scleritis	Eye disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Conjunctival hemorrhage	Eye disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Methaemoglobinaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0001 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Chest pain	General disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Influenza like illness	General disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Peripheral swelling	General disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Thirst	General disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Blister	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Night sweats	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Pruritis generalised	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Splinter haemorrhages	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Abdominal tenderness	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Hypoaesthesia oral	Gastrointestinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Abscess limb	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Candida infection	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Cellulitis staphylococcal	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Fungal skin infection	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Furuncle	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0013 affected13 at risk EG0020 affected16 at risk
Perirectal abscess	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Blood cholesterol increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Fibrin D dimer increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Vitamin D decreased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Weight decreased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Myopathy	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Ataxia	Nervous system disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Dystonia	Nervous system disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Lethargy	Nervous system disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0021 affected16 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Bradyphrenia	Psychiatric disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Hypomania	Psychiatric disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Rales	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Restrictive cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Ocular hyperaemia	Eye disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Periorbital oedema	Eye disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Cerumen impaction	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Cushingoid	Endocrine disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Blood lactate dehydrogenase increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Chills	General disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Pyrexia	General disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Chest discomfort	General disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Hordeolum	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Rhinitis	Infections and infestations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Viral infection	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Bronchiolitis	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Lung infection	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Urosepsis	Infections and infestations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Hypertensive crisis	Vascular disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Vasculitis	Vascular disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Blood creatine phosphokinase increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Blood potassium increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Eosinophil count increased	Investigations	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Blood bicarbonate increased	Investigations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Blood bilirubin unconjugated increased	Investigations	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Pulmonary granuloma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Scar	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Diplopia	Eye disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Lymphadenopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Renal failure acute	Renal and urinary disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Hydronephrosis	Renal and urinary disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Hydroureter	Renal and urinary disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Ureteric obstruction	Renal and urinary disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Deafness neurosensory	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected13 at risk EG0010 affected13 at risk EG0021 affected16 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected13 at risk EG0011 affected13 at risk EG0020 affected16 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected13 at risk EG0010 affected13 at risk EG0020 affected16 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama		United States

ID	Term
D056647	Systemic Vasculitis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C000620232	avacopan
D000069283	Rituximab
D005938	Glucocorticoids
D003520	Cyclophosphamide

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D000305	Adrenal Cortex Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D009930	Organic Chemicals
D063088	Phosphoramides
D009943	Organophosphorus Compounds

ID	Title	Description
BG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
BG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
BG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo BID Plus Standard of Care	Capsule, placebo, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	13	3	13	13	13
EG001	CCX168 10 mg BID Plus Standard of Care	Drug: CCX168 10 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	13	2	13	12	13
EG002	CCX168 30 mg BID Plus Standard of Care	Drug: CCX168 30 mg, twice daily plus cyclophosphamide/rituximab plus glucocorticoids	16	4	16	15	16

Term	Organ System	Assessment Type	Statistical Information
Methemoglobinemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk EG0020 events0 affected16 at risk
Gangrene	Infections and infestations	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk EG0020 events0 affected16 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk EG0020 events0 affected16 at risk
Cellulitis staphylococcal	Infections and infestations	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk EG0020 events0 affected16 at risk
Abscess limb	General disorders	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk EG0020 events0 affected16 at risk
Perirectal abscess	General disorders	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk EG0020 events0 affected16 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected13 at risk EG0022 events1 affected16 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected13 at risk EG0022 events1 affected16 at risk
Urinary tract infection	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected13 at risk EG0022 events1 affected16 at risk
Renal failure acute	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected13 at risk EG0021 events1 affected16 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk EG0020 events0 affected16 at risk
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk EG0020 events0 affected16 at risk

ID	Term
D056648	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
D014657	Vasculitis