Study of Cabiralizumab in Patients With Pigmented Villono... | NCT02471716 | Trialant
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Studies Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor NCT02471716 Show options Five Prime Therapeutics, Inc.
Pigmented Villonodular Synovitis Tenosynovial Giant Cell Tumor United States France Netherlands Poland South Korea United Kingdom Obsolete or Duplicate NCT IDs Not provided
Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor
A Phase 1/2 Study of Cabiralizumab, an Anti-CSF1 Receptor Antibody, in Patients With Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (Dt-TGCT)
Five Prime Therapeutics, Inc. INDUSTRY
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Jun 10, 2015
Results First Submitted Date Aug 4, 2021
Results First Submitted that Met QC Criteria Aug 4, 2021
Results First Posted Date Aug 31, 2021 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Aug 4, 2021
Responsible Party, by Official Title Sponsor
Five Prime Therapeutics, Inc. INDUSTRY
Has Data Monitoring Committee (DMC) Yes
Pediatric Postmarket Surveillance of a Device Product Not provided
This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.
A Phase 1/2 study was an open-label, dose escalation and dose expansion study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of cabiralizumab, a CSF1-R monoclonal antibody, inpatients with unresectable diffuse tenosynovial giant cell tumors (TGCT).
Pigmented Villonodular Synovitis Tenosynovial Giant Cell Tumor Diffuse Type Tenosynovial Giant Cell Tumor (dt-TGCT) Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Phase 1 FPA008 Dose Escalation Experimental IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose or lower dose that provide adequate PK exposure and biologic activity with tolerability.
Phase 2 FPA008 Dose Expansion Experimental IV infusion; once MTD and/or RD has been determined in Phase 1, expansion cohorts of approximately 30 patients (each cohort) with PVNS or dt-TGCT will be enrolled to characterize clinical activity and safety profile of the RD. Treatment is planned to continue for up to 24 weeks or 56 weeks.
Name Type Description Arm Group Labels Other Names FPA008 Biological FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Phase 1 FPA008 Dose Escalation Phase 2 FPA008 Dose Expansion
Measure Description Time Frame The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1
52 weeks The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2)
52 weeks
Measure Description Time Frame PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter
52 weeks Maximum Serum Concentration (Cmax).
Inclusion Criteria:
Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially resectable tumor that would result in unacceptable functional loss or morbidity as determined by a qualified surgeon or multi-disciplinary tumor board (must be documented in the CRF during screening)
Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI
ECOG performance status <1
Exclusion Criteria:
Prior therapy with an anti-CSF1R antibody
Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression on prior kinase inhibitor)
Liver function tests (including ALT, AST, and total bilirubin), outside of the range of local laboratory normal at Screening
Inadequate organ or bone marrow function
History of congestive heart failure or myocardial infarction <1 year prior to first study dose administration
Significant abnormalities on ECG at Screening
Contraindications to MRI and use of intravenous gadolinium-based contrast agents
Creatine Kinase ≥ 1.5x the upper limit of normal
Positive test for latent TB at Screening (Quantiferon test)
Active known or suspected autoimmune disease
Accepts Healthy Volunteers No
Name Affiliation Role Medical Lead Five Prime Therapeutics, Inc. Study Director
Facility Status City State ZIP Country Contacts Cedars-Sinai Medical Center Los Angeles California 90048 United States Sarcoma Oncology Research Center LLC
No data available
No data is available for this block.
ID Title Description FG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
FG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description Not provided
No data available
No data is available for this block.
Document Has No Statistical Analysis Plan (SAP) Not provided
Uploaded Document Information Type Includes Protocol Includes SAP Includes ICF Document Label Document Date Document Uploaded Date Document File Name Prot Yes No No Study Protocol Aug 24, 2016 Aug 4, 2021
No data available
No data is available for this block.
Non-Randomized
Intervention Model Description Not provided
Composite PK parameters of cabiralizumab: Maximum observed serum concentration
Minimum Serum Concentration (Cmin). Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin).
52 weeks
Pharmacokinetic Clearance (CL). Composite PK parameters of cabiralizumab: clearance (CL)
52 weeks
The Incidence of AEs. treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE.
52 weeks
The Incidence of Clinical Laboratory Abnormalities. The number of patients with a clinical laboratory that is outside the normal range at some time point during the study
52 weeks
The Incidence of ECG Abnormalities. The number of patients who had a change in their ECG that were clinically significant
52 weeks
Duration of Response Per RECIST 1.1 in Phase 2 The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2
52 weeks
Stanford Medicine Stanford California 94301-5821 United States
Dana-Farber Cancer Institute Boston Massachusetts 02215 United States
The University of Texas, MD Anderson Cancer Center Houston Texas 77030 United States
Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest Bordeaux 33076 France
Centre Léon Bérard Lyon 69008 France
Leiden University Medical Center Leiden 2333 ZA Netherlands
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie Warsaw 02-781 Poland
Seoul National University Hospital Seoul Jongno-gu 110-744 South Korea
University Hospitals Birmingham NHS Foundation Trust Birmingham B15 2TH United Kingdom
Oxford University Hospital NHS Trust Oxford OX3 7LE United Kingdom
FG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
FG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
FG004 Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
FG000 3 subjects
FG001 3 subjects
FG002 3 subjects
FG003 33 subjects
FG004 24 subjects COMPLETED FG000 3 subjects FG001 2 subjects FG002 3 subjects FG003 18 subjects FG004 8 subjects
NOT COMPLETED FG000 0 subjects FG001 1 subjects FG002 0 subjects FG003 15 subjects FG004 16 subjects
Type Comment Reasons Withdrawal by Subject FG000 0 subjects FG001 1 subjects FG002 0 subjects FG003 2 subjects FG004 5 subjects Study Terminiated by sponsor FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 1 subjects FG004 Lost to Follow-up FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 3 subjects FG004 Death FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 1 subjects FG004 Other FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 8 subjects FG004
Type of Units Analyzed
ID Title Description BG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
BG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
BG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
BG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
BG004 Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
BG005 Total Total of all reporting groups
Units Counts Participants BG000 3 BG001 3 BG002 3 BG003 33 BG004 24 BG005 66
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Categorical Count of Participants Participants Title Denominators Categories Title Measurements <=18 years
Age, Continuous Mean Standard Deviation years Title Denominators Categories Title Measurements BG000 37.7 ± 11.24 BG001 40.7 ± 23.07 BG002
Sex: Female, Male Count of Participants Participants Title Denominators Categories
Race/Ethnicity, Customized Count of Participants Participants Title Denominators Categories American Indian/alaska Native
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 The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1
Posted Count of Participants Participants 52 weeks ID Title Description OG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
OG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
OG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
Title Denominators Categories
Primary The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2)
Posted Count of Participants Participants 52 weeks ID Title Description OG000 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG001 Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Secondary PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter
Posted Geometric Mean Geometric Coefficient of Variation ug x day/mL 52 weeks ID Title Description OG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
OG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
OG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
OG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG004 Phase 2 FPA008 Dose Expansion Cohort 2B
Secondary Maximum Serum Concentration (Cmax). Composite PK parameters of cabiralizumab: Maximum observed serum concentration
Posted Geometric Mean Geometric Coefficient of Variation ug/mL 52 weeks ID Title Description OG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
OG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
OG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
OG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG004 Phase 2 FPA008 Dose Expansion Cohort 2B
Secondary Minimum Serum Concentration (Cmin). Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin).
Posted Geometric Mean Geometric Coefficient of Variation ug/mL 52 weeks ID Title Description OG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
OG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
OG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
OG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG004 Phase 2 FPA008 Dose Expansion Cohort 2B
Secondary Pharmacokinetic Clearance (CL). Composite PK parameters of cabiralizumab: clearance (CL)
Posted Geometric Mean Geometric Coefficient of Variation L/d 52 weeks ID Title Description OG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
OG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
OG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
OG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG004 Phase 2 FPA008 Dose Expansion Cohort 2B
Secondary The Incidence of AEs. treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE.
Posted Count of Participants Participants 52 weeks ID Title Description OG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
OG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
OG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
OG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG004 Phase 2 FPA008 Dose Expansion Cohort 2B
Secondary The Incidence of Clinical Laboratory Abnormalities. The number of patients with a clinical laboratory that is outside the normal range at some time point during the study
Posted Number participants 52 weeks ID Title Description OG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
OG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
OG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
OG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG004 Phase 2 FPA008 Dose Expansion Cohort 2B
Secondary The Incidence of ECG Abnormalities. The number of patients who had a change in their ECG that were clinically significant
The changes in the ECG parameters were not clinically significant in any dosing cohort in the study
Posted Count of Participants Participants 52 weeks ID Title Description OG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
OG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
OG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
OG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG004
Secondary Duration of Response Per RECIST 1.1 in Phase 2 The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2
Posted Median 95% Confidence Interval months 52 weeks ID Title Description OG000 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
OG001 Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Phase 1 FPA008 Dose Escalation 1mg/kg Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks
0 3 0 3 3 3 EG001 Phase 1 FPA008 Dose Escalation 2mg/kg Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks
0 3 0 3 3 3 EG002 Phase 1 FPA008 Dose Escalation 4mg/kg Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
0 3 2 3 3 3 EG003 Phase 2 FPA008 Dose Expansion Cohort 2A Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses.
1 32 8 33 33 33 EG004 Phase 2 FPA008 Dose Expansion Cohort 2B Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
0 24 6 24 24 24
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Anaemia Blood and lymphatic system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 3 affected 33 at risk EG004 0 affected 24 at risk Lymphadenopathy Blood and lymphatic system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Neutropenia Blood and lymphatic system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Palpitations Cardiac disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Sinus bradycardia Cardiac disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Sinus tachycardia Cardiac disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hearing impaired Ear and labyrinth disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Tinnitus Ear and labyrinth disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Cushingoid Endocrine disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Abnormal sensation in eye Eye disorders Systematic Assessment EG000 1 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Conjunctival hyperaemia Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Conjunctival oedema Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Dry eye Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Eye pain Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Eyelid oedema Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Eyelid rash Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Eyelid skin dryness Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Lacrimation increased Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Periorbital oedema Eye disorders Systematic Assessment EG000 2 affected 3 at risk EG001 2 affected 3 at risk EG002 2 affected 3 at risk EG003 Photophobia Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Scleritis Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Vision blurred Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Visual acuity reduced Eye disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Abdominal pain upper Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Colitis Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Constipation Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Diarrhoea Gastrointestinal disorders Systematic Assessment EG000 1 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Diarrhoea haemorrhagic Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Food poisoning Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Haemorrhoids Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Lip swelling Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Nausea Gastrointestinal disorders Systematic Assessment EG000 2 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Oral pain Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Vomiting Gastrointestinal disorders Systematic Assessment EG000 1 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Abdominal discomfort Gastrointestinal disorders Systematic Assessment EG000 1 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Abdominal pain Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Cheilitis Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Flatulence Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Lip oedema Gastrointestinal disorders Systematic Assessment EG000 1 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Salivary hypersecretion Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Stomatitis Gastrointestinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Asthenia General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Chest pain General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Chills General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Face oedema General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 2 affected 3 at risk EG003 Fatigue General disorders Systematic Assessment EG000 2 affected 3 at risk EG001 1 affected 3 at risk EG002 3 affected 3 at risk EG003 Gait disturbance General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Generalised oedema General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Local swelling General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Non-cardiac chest pain General disorders Systematic Assessment EG000 1 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Oedema General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Oedema peripheral General disorders Systematic Assessment EG000 2 affected 3 at risk EG001 1 affected 3 at risk EG002 2 affected 3 at risk EG003 Pain General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Peripheral swelling General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Pyrexia General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Sensation of foreign body General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Swelling General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Biliary colic Hepatobiliary disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Cholelithiasis Hepatobiliary disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hepatic pain Hepatobiliary disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hepatocellular injury Hepatobiliary disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Abscess Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Acarodermatitis Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Cellulitis Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Conjunctivitis Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Ear infection Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Gastroenteritis Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hordeolum Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Influenza Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Ophthalmic herpes zoster Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Oral candidiasis Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Otitis externa Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Pneumonia Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Respiratory tract infection Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Urinary tract infection Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Viral infection Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Vulvovaginal candidiasis Infections and infestations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Localised oedema General disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Contusion Injury, poisoning and procedural complications Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Joint dislocation Injury, poisoning and procedural complications Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Joint injury Injury, poisoning and procedural complications Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Post procedural inflammation Injury, poisoning and procedural complications Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Activated partial thromboplastin time prolonged Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Alanine aminotransferase increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 2 affected 3 at risk EG003 Aspartate aminotransferase increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 2 affected 3 at risk EG003 Blood alkaline phosphatase increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Blood bilirubin increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Blood cholesterol increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Blood creatine phosphokinase increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 3 affected 3 at risk EG003 Blood lactate dehydrogenase increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Blood pressure increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 C-reactive protein increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Troponin I increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Weight increased Investigations Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Decreased appetite Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hypercalcaemia Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hypercholesterolaemia Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hyperglycaemia Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hypertriglyceridaemia Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hypoglycaemia Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hypokalaemia Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Hyponatraemia Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hypophosphataemia Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Increased appetite Metabolism and nutrition disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Arthralgia Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Arthritis Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Back pain Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Flank pain Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Joint effusion Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Joint range of motion decreased Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Joint swelling Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Knee deformity Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Lupus-like syndrome Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Mobility decreased Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Muscle spasms Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Musculoskeletal discomfort Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Musculoskeletal pain Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Musculoskeletal stiffness Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Myalgia Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Neck pain Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Pain in extremity Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Pain in jaw Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Rhabdomyolysis Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Spinal pain Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Synovitis Musculoskeletal and connective tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Bladder cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Haemangioma of bone Neoplasms benign, malignant and unspecified (incl cysts and polyps) Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Tumour pain Neoplasms benign, malignant and unspecified (incl cysts and polyps) Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Burning sensation Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Carpal tunnel syndrome Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Cervicobrachial syndrome Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dizziness Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dysgeusia Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Headache Nervous system disorders Systematic Assessment EG000 1 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hyperaesthesia Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hypoaesthesia Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Migraine Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Neuralgia Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Neuropathy peripheral Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Nystagmus Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Paraesthesia Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Poor quality sleep Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Sciatica Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Tremor Nervous system disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Affective disorder Psychiatric disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Anxiety Psychiatric disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Insomnia Psychiatric disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Bladder spasm Renal and urinary disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dysuria Renal and urinary disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Haematuria Renal and urinary disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dysfunctional uterine bleeding Reproductive system and breast disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Menometrorrhagia Reproductive system and breast disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Menorrhagia Reproductive system and breast disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Menstruation irregular Reproductive system and breast disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Pelvic pain Reproductive system and breast disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dysphonia Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Dyspnoea Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dyspnoea exertional Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Laryngeal oedema Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Nasal congestion Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Pleural effusion Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Productive cough Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Rhinitis allergic Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Rhinorrhoea Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Sleep apnoea syndrome Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Wheezing Respiratory, thoracic and mediastinal disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Acne Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Cold sweat Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dermatitis Skin and subcutaneous tissue disorders Systematic Assessment EG000 2 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dermatitis acneiform Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Drug eruption Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Dry skin Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 2 affected 3 at risk EG003 Eczema Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Erythema Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Generalised erythema Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hirsutism Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hyperhidrosis Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Macule Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Mechanical urticaria Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Night sweats Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Pain of skin Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Petechiae Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Photosensitivity reaction Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Pruritus Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Pruritus generalised Skin and subcutaneous tissue disorders Systematic Assessment EG000 1 affected 3 at risk EG001 1 affected 3 at risk EG002 1 affected 3 at risk EG003 Psoriasis Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Rash Skin and subcutaneous tissue disorders Systematic Assessment EG000 1 affected 3 at risk EG001 1 affected 3 at risk EG002 2 affected 3 at risk EG003 Rash erythematous Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Rash generalised Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Rash macular Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Rash maculo-papular Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 1 affected 3 at risk EG002 0 affected 3 at risk EG003 Rash papular Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Rash pruritic Skin and subcutaneous tissue disorders Systematic Assessment EG000 1 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Skin atrophy Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Skin discolouration Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Skin disorder Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 2 affected 3 at risk EG003 Skin exfoliation Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Skin hyperpigmentation Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Skin lesion Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Skin striae Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Swelling face Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Urticaria Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 1 affected 3 at risk EG003 Xeroderma Skin and subcutaneous tissue disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003 Hypertension Vascular disorders Systematic Assessment EG000 0 affected 3 at risk EG001 0 affected 3 at risk EG002 0 affected 3 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? No
Title Organization Phone Extension Email Medical FivePrime Theraputics 415-365-5600 nick.mahasuwan@fiveprime.com
SAP No Yes No Statistical Analysis Plan Jan 29, 2020 Aug 4, 2021
ID Term D013586 Synovitis, Pigmented Villonodular D000070779 Giant Cell Tumor of Tendon Sheath
ID Term D005870 Giant Cell Tumors D009372 Neoplasms, Connective Tissue D018204 Neoplasms, Connective and Soft Tissue D009370 Neoplasms by Histologic Type D009369 Neoplasms D013585 Synovitis D007592 Joint Diseases D009140 Musculoskeletal Diseases D052256 Tendinopathy D009135 Muscular Diseases
ID Term C000722457 cabiralizumab
0 subjects
2 subjects
0 subjects
9 subjects
0
BG004 0
BG005 0 Between 18 and 65 years BG000 3 BG001 2 BG002 3 BG003 32 BG004 22 BG005 62
>=65 years BG000 0 BG001 1 BG002 0 BG003 1 BG004 2 BG005 4
41.7
± 7.51
BG003 38 ± 12.77
BG004 44.1 ± 15.32
BG005 40.8 ± 14.03 1
BG003 23
BG004 10
BG005 40 Male BG000 0 BG001 0 BG002 2 BG003 10 BG004 14 BG005 26
0
BG003 0
BG004 0
BG005 0 Black Title Measurements BG000 0 BG001 0 BG002 0 BG003 0 BG004 2 BG005 2
Native Hawaiian/Pacific Islander Title Measurements BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0
White Title Measurements BG000 3 BG001 2 BG002 2 BG003 9 BG004 9 BG005 25
Asian Title Measurements BG000 0 BG001 1 BG002 0 BG003 5 BG004 1 BG005 7
Other Title Measurements BG000 0 BG001 0 BG002 0 BG003 19 BG004 8 BG005 27
Unknown Title Measurements BG000 0 BG001 0 BG002 1 BG003 0 BG004 4 BG005 5
32
OG001 24 Title Denominators Categories
Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Units Counts Participants OG000 3 OG001 2 OG002 1 OG003 2 OG004 3
Title Denominators Categories Title Measurements OG000 102 ± 10.2 OG001 283 ± 26.3 OG002 593 ± 31.3 OG003 660 ± 17.7 OG004 593 ± 12.6
Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 30 OG004 24
Title Denominators Categories Title Measurements OG000 22.5 ± 14.3 OG001 52.1 ± 22 OG002 91.2 ± 15 OG003 91.8 ± 24.8 OG004 87 ± 12.6
Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 30 OG004 24
Title Denominators Categories Title Measurements OG000 2.18 ± 117 OG001 7.26 ± 41.8 OG002 21.2 ± 59.2 OG003 23.9 ± 38.3 OG004 22.6 ± 28.2
Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Units Counts Participants OG000 3 OG001 2 OG002 1 OG003 2 OG004 3
Title Denominators Categories Title Measurements OG000 .663 ± 16.6 OG001 .416 ± 24.5 OG002 .694 ± 0 OG003 .307 ± 44.9 OG004 .525 ± 8.42
Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 33 OG004 24
Title Denominators Categories Title Measurements OG000 3 OG001 3 OG002 3 OG003 33 OG004 24
Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Units Counts Participants OG000 3 OG001 2 OG002 3 OG003 33 OG004 24
Title Denominators Categories Title Measurements OG000 3 OG001 2 OG002 3 OG003 33 OG004 24
Phase 2 FPA008 Dose Expansion Cohort 2B
Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
Units Counts Participants OG000 3 OG001 3 OG002 3 OG003 33 OG004 24
Title Denominators Categories Title Measurements OG000 0 OG001 0 OG002 0 OG003 0 OG004 0
8
OG001 8 Title Denominators Categories Title Measurements OG000 4.4 (3.2 to NA) the upper bound of the confidence interval was not reached OG001 NA (11.5 to NA) The median duration of response was not reached
1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 2 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 6 affected
33 at risk
EG004 7 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 4 affected
33 at risk
EG004 5 affected 24 at risk 20 affected
33 at risk
EG004 13 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 3 affected
33 at risk
EG004 5 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 2 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 3 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 5 affected
33 at risk
EG004 3 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 4 affected
33 at risk
EG004 3 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 3 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 0 affected 24 at risk 7 affected
33 at risk
EG004 5 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 1 affected 24 at risk 22 affected
33 at risk
EG004 12 affected 24 at risk 11 affected
33 at risk
EG004 8 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 2 affected 24 at risk 19 affected
33 at risk
EG004 8 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 3 affected 24 at risk 5 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 2 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 2 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 6 affected
33 at risk
EG004 0 affected 24 at risk 10 affected
33 at risk
EG004 3 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 2 affected
33 at risk
EG004 0 affected 24 at risk 4 affected
33 at risk
EG004 0 affected 24 at risk 21 affected
33 at risk
EG004 16 affected 24 at risk 4 affected
33 at risk
EG004 3 affected 24 at risk 0 affected
33 at risk
EG004 1 affected 24 at risk 1 affected
33 at risk
EG004 0 affected 24 at risk 1 affected
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