Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-03... | NCT02959918 | Trialant
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Studies Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid NCT02959918 Show options Selecta Biosciences, Inc.
Gout Chronic Hyperuricemia SEL-212 SEL-037 SVP-rapamycin (SEL-110) Obsolete or Duplicate NCT IDs Not provided
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
An Open Label Phase II Multiple Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 Followed by Open Label Administration of SEL-037 in Subjects With Symptomatic Gout and Elevated Blood Uric Acid
Selecta Biosciences, Inc. INDUSTRY
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Nov 8, 2016
Results First Submitted Date Apr 2, 2021
Results First Submitted that Met QC Criteria Jan 31, 2022
Results First Posted Date Feb 14, 2022 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 Jan 31, 2022
Responsible Party, by Official Title Sponsor
Selecta Biosciences, Inc. INDUSTRY
Has Data Monitoring Committee (DMC) No
Pediatric Postmarket Surveillance of a Device Product Not provided
This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase (SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses ( 5 monthly IV infusions) of pegsiticase (SEL-037) alone.
Participants will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will be drawn at pre-determined time points in addition to weekly serum uric acid levels.
This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase ( SEL-037, also known as pegadricase) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in participants with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses (5 monthly IV infusions) of pegsiticase (SEL-037) alone.
Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. All participants will be monitored for safety and tolerability to drug throughout the study on a weekly schedule. Pharmacokinetic and pharmacodynamic parameters will at specific timepoints to monitor for continued efficacy. Pharmacodynamic parameters measured include uric acid levels and levels of ADAs.
The study duration per enrolled participant will be approximately 6 months including a 1 month screening period followed by 5 treatment cycles and an end of treatment visit which will occur 30 days after the last IV infusion .
Gout Chronic Hyperuricemia 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 SEL-037 Pegadricase LD (low dose) alone Experimental Pegadricase 0.2 mg/kg intravenous (IV) every 28 days for 5 treatments
SEL-037 Pegadricase HD (high dose) alone Experimental Pegadricase 0.4 mg/kg intravenous (IV) every 28 days for 5 treatments
SEL-212, Pegadricase LD & SEL-110 (1a) Experimental Pegadricase 0.2 mg/kg IV plus SEL-110 0.05 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110) SEL-212, Pegadricase HD & SEL-110 (1b) Experimental Pegadricase 0.4 mg/kg IV plus SEL-110 0.05 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110) SEL-212, Pegadricase LD & SEL-110 (2a) Experimental Pegadricase 0.2 mg/kg IV plus SEL-110 0.08 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments
Name Type Description Arm Group Labels Other Names SEL-212 Drug SEL-212, Pegadricase HD & SEL-110 (1b) SEL-212, Pegadricase HD & SEL-110 (2b) SEL-212, Pegadricase HD & SEL-110 (3a)
Measure Description Time Frame Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set
Five monthly infusions
Measure Description Time Frame Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA < 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects
3 and 5 months
Inclusion Criteria:
Adult (age 21-75 inclusive) men and women of non child bearing potential with established or symptomatic gout which is defined as having at least ONE of any of the 3 following factors:
≥ 1 tophus
1 gout flare within the last 6 months
Chronic gouty arthropathy
Screening serum uric acid of >6 mg/dL
On a gout flare prophylactic regimen for 7 days prior to first dose
Willing to provide written informed consent prior to first study procedure is performed.
Understands and is willing and able to comply with study requirements, including the schedule of follow-up visits.
Exclusion Criteria:
History of anaphylaxis or severe allergic reaction.
History of an allergy to pegylated products.
Women of child bearing potential, Defined as:
<6 weeks after surgical bilateral salpingooperhectony with or without hysterectomy
Pre or perimenopausal ( < less than 24 months of natural amenorrhea)
Initiation or change in dose of hormone-replacement therapy for menopausal women less than 1 month prior to the Screening Visit or during the Screening Phase would be exclusionary. If after being on a stable dose of hormone-replacement therapy for one month the patient may be considered for the study if she continues to meet all other inclusion and exclusion criteria
Uncontrolled diabetes with baseline HbA1c ≥8%;
Glucose-6-phosphate dehydrogenase deficiency;
Uncontrolled hypertension
Ongoing treatment for arrhythmia, including placement of an implantable defibrillator;
History of coronary artery disease, including myocardial infarction;
Congestive heart failure, New York Heart Association Class III or IV;
ECG with evidence of prior myocardial infarction, clinically significant arrhythmia, or other abnormalities that, in the opinion of the investigator, are consistent with significant underlying cardiac disease;
History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek, Fasturtec), pegloticase (Krystexxa®), pegsiticase (SEL-037)
History of malignancy within the last 5 years other than basal skin cancer;
Subjects who, in the opinion of the investigator, present with a condition that would compromise their safety or that would make study completion unlikely.
Accepts Healthy Volunteers No
Facility Status City State ZIP Country Contacts Anaheim Clinical Trials Anaheim California 92801 United States Tri West Research Associates LLC
PubMed Identifier Type Citation Retractions Derived Kivitz A, DeHaan W, Azeem R, Park J, Rhodes S, Inshaw J, Leung SS, Nicolaou S, Johnston L, Kishimoto TK, Traber PG, Sands E, Choi H. Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110). Rheumatol Ther. 2023 Aug;10(4):825-847. doi: 10.1007/s40744-023-00546-0. Epub 2023 Apr 17.
Available IPD Information Not provided
ID Title Description FG000 SEL-037 (Pegadricase) Low Dose Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
FG001 SEL-037 (Pegadricase) High Dose Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
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 Mar 19, 2018 Apr 1, 2021
No data available
No data is available for this block.
No data available
No data is available for this block.
Randomized
Intervention Model Description Not provided
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110) SEL-212, Pegadricase HD & SEL-110 (2b) Experimental Pegadricase 0.4 mg/kg IV plus SEL-110 0.08 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (3a) Experimental Pegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (3b) Experimental Pegadricase 0.4 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (4a) Experimental Pegadricase 0.4 mg/kg IV plus SEL-110 0.125 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (4b) Experimental Pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.2 mg/kg IV every 28 days for 2 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (5a) Experimental Pegadricase 0.4 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 3 treatments, followed by pegadricase 0.4 mg/kg IV every 28 days for 2 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (5b) Experimental Pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 5 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (6a) Experimental Pegadricase 0.2 mg/kg IV plus SEL-110 0.10 mg/kg IV every 28 days for 1 treatment followed by pegadricase 0.2 mg/kg IV plus SEL-110 0.15 mg/kg IV every 28 days for 4 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (6b) Experimental Pegadricase 0.2 mg/kg IV plus SEL-110 0.1 mg/kg IV every 28 days for 5 treatments
Drug: SEL-212 Drug: SVP-rapamycin (SEL-110)
SEL-212, Pegadricase HD & SEL-110 (3b)
SEL-212, Pegadricase HD & SEL-110 (4a)
SEL-212, Pegadricase HD & SEL-110 (4b)
SEL-212, Pegadricase HD & SEL-110 (5a)
SEL-212, Pegadricase HD & SEL-110 (5b)
SEL-212, Pegadricase HD & SEL-110 (6a)
SEL-212, Pegadricase HD & SEL-110 (6b)
SEL-212, Pegadricase LD & SEL-110 (1a)
SEL-212, Pegadricase LD & SEL-110 (2a) Pegadricase plus SVP-rapamycin
SEL-037 Drug SEL-037 Pegadricase HD (high dose) alone SEL-037 Pegadricase LD (low dose) alone
SVP-rapamycin (SEL-110) Drug SEL-212, Pegadricase HD & SEL-110 (1b) SEL-212, Pegadricase HD & SEL-110 (2b) SEL-212, Pegadricase HD & SEL-110 (3a) SEL-212, Pegadricase HD & SEL-110 (3b) SEL-212, Pegadricase HD & SEL-110 (4a) SEL-212, Pegadricase HD & SEL-110 (4b) SEL-212, Pegadricase HD & SEL-110 (5a) SEL-212, Pegadricase HD & SEL-110 (5b) SEL-212, Pegadricase HD & SEL-110 (6a) SEL-212, Pegadricase HD & SEL-110 (6b) SEL-212, Pegadricase LD & SEL-110 (1a) SEL-212, Pegadricase LD & SEL-110 (2a)
Irvine Center for Clinical Research Inc. Irvine California 92614 United States
Clinical Research of West Florida Clearwater Florida 33765 United States
Omega Research Consultants LLC DeBary Florida 32713 United States
Compass Research LLC Orlando Florida 32806 United States
East-West Medical Research Institute Honolulu Hawaii 96814 United States
Advanced Clinical Research Boise Idaho 83642 United States
L-MARC Louisville Kentucky 40213 United States
Triad Clinical Trials LLC Greensboro North Carolina 27410 United States
New Horizons Clinical Research Cincinnati Ohio 45242 United States
Altoona Center for Clinical Research Duncansville Pennsylvania 16635 United States
Advanced Clinical Research West Jordan Utah 84088 United States
FG002 SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
FG003 SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
FG004 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
FG005 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
FG006 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
FG007 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
FG008 SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
FG009 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
FG010 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
FG011 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
FG012 SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low for 4 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 dose then SEL-110 (0.1 mg/kg) + Pegadricase 0.2 mg/kg every 28 days for 4 doses
FG013 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
FG000 3 subjects
FG001 3 subjects
FG002 9 subjects
FG003 10 subjects
FG004 6 subjects
FG005 11 subjects
FG006 11 subjects
FG007 12 subjects
FG008 14 subjects
FG009 13 subjects
FG010 14 subjects
FG011 23 subjects
FG012 11 subjects
FG013 12 subjects COMPLETED FG000 0 subjects FG001 0 subjects FG002 1 subjects FG003 1 subjects FG004 1 subjects FG005 5 subjects FG006 6 subjects FG007 6 subjects FG008 7 subjects FG009 7 subjects FG010 8 subjects FG011 11 subjects FG012 4 subjects FG013 6 subjects
NOT COMPLETED FG000 3 subjects FG001 3 subjects FG002 8 subjects FG003 9 subjects FG004 5 subjects FG005 6 subjects FG006 5 subjects FG007 6 subjects FG008 7 subjects FG009 6 subjects FG010 6 subjects FG011 12 subjects FG012 7 subjects FG013 6 subjects
Type Comment Reasons Adverse Event FG000 1 subjects FG001 1 subjects FG002 2 subjects FG003 0 subjects FG004 0 subjects FG005 2 subjects FG006 2 subjects FG007 1 subjects FG008 2 subjects FG009 1 subjects FG010 1 subjects FG011 3 subjects FG012 2 subjects FG013 4 subjects Lost to Follow-up FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 Withdrawal by Subject FG000 0 subjects FG001 0 subjects FG002 1 subjects FG003 2 subjects FG004 Protocol Violation FG000 0 subjects FG001 0 subjects FG002 1 subjects FG003 0 subjects FG004 Stopping Rule Met FG000 1 subjects FG001 0 subjects FG002 3 subjects FG003 4 subjects FG004 Sponsor Decision, Pause in Clinical Trial FG000 1 subjects FG001 2 subjects FG002 1 subjects FG003 3 subjects FG004 Subject Hospitalized, out of window for next dosing period FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects PI Discretion due to abnormal Hgb results FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 Subject under-dosed with study drug and removed by Sponsor FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects
Type of Units Analyzed
ID Title Description BG000 SEL-037 (Pegadricase) Low Dose Pegardricase 0.2 mg/kg every 28 days for up to 5 doses
BG001 SEL-037 (Pegadricase) High Dose Pegardricase 0.4 mg/kg every 28 days for up to 5 doses
BG002 SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
BG003 SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
BG004 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
BG005 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
BG006 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
BG007 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
BG008 SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
BG009 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
BG010 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
BG011 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
BG012 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low for 1 Dose Then SEL-110 0.1 mg/kg + SEL-037 Low 4 Doses SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 1 Dose Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 4 Doses
BG013 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
BG014 Total Total of all reporting groups
Units Counts Participants BG000 3 BG001 3 BG002 9 BG003 10 BG004 6 BG005 11 BG006 11 BG007 12 BG008 14 BG009 13 BG010 14 BG011 23 BG012 11 BG013 12 BG014 152
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
Sex: Female, Male Count of Participants Participants Title Denominators Categories
Race/Ethnicity, Customized Count of Participants Participants Title Denominators Categories Number Analyzed Title Measurements American Indian or 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 Safety and Tolerability of Multiple Intravenous Infusions of SEL-037 or SEL-212 as Assessed by the Percentage of Participants Experiencing Serious Adverse Events and Those Adverse Events Reported by 5 Percentage or More in the Safety Analysis Set To determine the safety and tolerability of SEL-037 (pegadricase) after up to 5 monthly infusions, of SEL-212 for 3 monthly infusions followed by 2 monthly infusions of SEL-037 (pegadricase), or of SEL-212 for 5 monthly infusions as assessed by the percentage of participants in a treatment arm experiencing serious adverse events and percentage of participants experiencing those adverse events that were reported by 5 or more percentage of participants in any arm in the safety analysis set
Safety analysis set, dosed subjects
Posted Count of Participants Participants Five monthly infusions ID Title Description OG000 SEL-037 (Pegadricase) Low Dose Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
OG001 SEL-037 (Pegadricase) High Dose Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
OG002 SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
OG003 SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG004 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + SEL-037 (pegadricase) 0.2 mg/kg every 28 days for 3 doses followed by SEL-037 0.2 mg/kg every 28 days for 2 doses
OG005 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG006 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
OG007 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG008 SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG009 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
OG010 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG011 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
OG012 SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 Doses
OG013 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
Title Denominators Categories
Secondary Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA < 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects
Eligible subjects are those who received the entire first dose, did not discontinue due to withdrawal of consent (during TP 1-4), a protocol deviation (during TP1-2) or a non-study drug-related SAE (during TP1-2). The outcome data is presented with arms combined by regimen (i.e. SEL-037 alone; SEL-212 for 3 doses & SEL-037 for 2 doses; or SEL-212 for 5 doses) rather than by dosing arm as the outcome is most effected by the SEL-212 combination which results in suppression of anti-drug antibodies.
Posted Count of Participants Participants 3 and 5 months ID Title Description OG000 SEL-037 (Pegadricase) SEL-037 every 28 days for up to 5 doses
OG001 SEL-212 for 3 Doses Followed by SEL-037 for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) + SEL-037 (pegadricase) every 28 days for 3 doses followed by SEL-037 every 28 days for 2 doses
OG002 SEL-212 for 5 Doses
Secondary Number of Participants With Reduced Serum Uric Acid After Multiple Monthly IV Infusions With or Without SEL-110 Measurement of the number of participants with reduced serum uric acid after multiple monthly infusions with or without SEL-110 as determined by values of sUA < 6 mg/dL at the end of Treatment Period 3 and at the end of Treatment Period 5 in eligible subjects
Posted Count of Participants Participants 3 and 5 months ID Title Description OG000 SEL-037 (Pegadricase) Low Dose Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
OG001 SEL-037 (Pegadricase) High Dose Pegadricase 0.4mg/kg IV every 28 days for up to 5 doses
OG002 SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
OG003 SEL-212: SEL-110(0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037(0.4 mg/kg) for 2 Doses
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 SEL-037 (Pegadricase) Low Dose Pegadricase 0.2 mg/kg IV every 28 days for up to 5 doses
0 3 1 3 3 3 EG001 SEL-037 (Pegadricase) High Dose Pegadricase 0.4 mg/kg IV every 28 days for up to 5 doses
0 3 1 3 3 3 EG002 SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
0 9 2 9 8 9 EG003 SEL-212: SEL-110 (0.05 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
0 10 0 10 8 10 EG004 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
0 6 0 6 6 6 EG005 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
0 11 1 11 10 11 EG006 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
0 11 2 11 10 11 EG007 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
0 12 4 12 12 12 EG008 SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
0 14 2 14 14 14 EG009 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg IV every 28 days for 2 doses
0 13 0 13 12 13 EG010 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg IV every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg IV every 28 days for 2 doses
0 14 1 14 14 14 EG011 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses
0 23 3 23 21 23 EG012 SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low Dose x 4 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 dose then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 doses IV every 28 days
0 11 1 11 9 11 EG013 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg IV every 28 days for 5 doses
0 12 2 12 12 12
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Acute Myocardial Infarction Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 0 events 0 affected 10 at risk EG004 0 events 0 affected 6 at risk EG005 0 events 0 affected 11 at risk EG006 0 events 0 affected 11 at risk EG007 0 events 0 affected 12 at risk EG008 1 events 1 affected 14 at risk EG009 0 events 0 affected 13 at risk EG010 0 events 0 affected 14 at risk EG011 0 events 0 affected 23 at risk EG012 0 events 0 affected 11 at risk EG013 0 events 0 affected 12 at risk Atrioventricular block Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Arrhythmia Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Cardiac failure Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Acute Pancreatitis Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dysphagia Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Peripheral oedema General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Acute cholecystitis Hepatobiliary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Cholecystitis Hepatobiliary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Anaphylactic reaction Immune system disorders MedDRA (21.1) Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Anaphylactic shock Immune system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Cellulitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pneumonia Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pyelonephritis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Soft tissue infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Infusion related reaction Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Dehydration Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Gout flare Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Acute kidney injury Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Micturition disorder Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Renal tubular necrosis Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Gout flare Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 3 events 3 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 2 events 2 affected 9 at risk EG003 2 events 2 affected 10 at risk EG004 4 events 2 affected 6 at risk EG005 3 events 2 affected 11 at risk EG006 8 events 4 affected 11 at risk EG007 10 events 4 affected 12 at risk EG008 15 events 6 affected 14 at risk EG009 10 events 4 affected 13 at risk EG010 10 events 4 affected 14 at risk EG011 23 events 8 affected 23 at risk EG012 9 events 5 affected 11 at risk EG013 21 events 5 affected 12 at risk Hyperglycaemia Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Hypophosphataemia Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 5 events 4 affected 9 at risk EG003 Diarrhoea Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Stomatitis Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Upper respiratory tract infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Headache Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Anaemia Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Leukopenia Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Rash Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Flushing Vascular disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Anaphylactic reaction Immune system disorders MedDRA (21.1) Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Musculoskeletal stiffness Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pruritus Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hypertension Vascular disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Anaphylactic shock Immune system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Infusion related reaction Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Tachycardia Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 3 events 2 affected 9 at risk EG003 Rhinitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Sinusitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Vomiting Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Flank pain Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Cellulitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Anxiety Psychiatric disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Paraesthesia Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Hypogeusia Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Hyperlipidaemia Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Micturition urgency Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Bronchitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 2 events 2 affected 9 at risk EG003 Paraesthesia oral Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Influenza Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Lymphopenia Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Chest discomfort General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Asthma Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Hyperfibrinogenaemia Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Thrombocytosis Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Leukocytosis Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Skin infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 1 events 1 affected 9 at risk EG003 Toothache Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Osteoarthritis Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hypertriglyceridaemia Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Patellofemoral pain syndrome Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Lymphadenopathy Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Nasopharyngitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Chromaturia Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Presyncope Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dermatitis contact Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Back pain Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Skin laceration Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pain in extremity Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Arthralgia Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Thrombocytopenia Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Nausea Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Laryngitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Bowel movement irregularity Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Stress Psychiatric disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dyspepsia Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Weight increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Blood triglycerides increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pollakiuria Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Muscle strain Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Joint injury Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Joint effusion Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Tendon injury Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Gingivitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hypokalaemia Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Sciatica Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Oedema peripheral General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Oesophageal oedema Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Formication Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Urine odour abnormal Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Tinnitus Ear and labyrinth disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Type 2 diabetes mellitus Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dysgeusia Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Infusion site extravasation General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Seasonal allergy Immune system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Eye pain Eye disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hand dermatitis Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Catheter site pain General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Trichomoniasis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Musculoskeletal Pain Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Skin abrasion Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Nocturia Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Neutropenia Blood and lymphatic system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dizziness Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Cholecystitis Hepatobiliary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Vasospasm Vascular disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Migraine Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Gastrooesophageal reflux disease Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 alopecia Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 myalgia Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Lip swelling Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Palpitations Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 epicondylitis Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Rash papular Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Muscle spasms Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 burning sensation Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 urinary tract infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 blood creatinine increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 atrioventricular block second degree Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 acute kidney injury Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pleurisy Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pancreatitis acute Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Cholecystitis acute Hepatobiliary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hepatic enzyme increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Swelling of eyelid Eye disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dermatitis allergic Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Abdominal pain Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Plantar fasciitis Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Tendonitis Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Metatarsalgia Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Oral mucosa haematoma Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Aphthous ulcer Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Electrocardiogram QT prolonged Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dental caries Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Diabetic neuropathy Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Decreased appetite Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Night sweats Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pain General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dysphonia Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Ear pain Ear and labyrinth disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Alanine aminotransferase increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 aspartate aminotransferase increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Urticaria Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Phlebitis superficial Vascular disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Varicose vein Vascular disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Tooth abscess Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 viral upper respiratory tract infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Electrocardiogram T wave abnormal Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pyrexia General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Gingival pain Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Joint stiffness Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Joint swelling Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Actinic keratosis Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Folliculitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Contusion Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Seborrhoeic keratosis Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Prostate infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pneumonia Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Prinzmetal angina Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Acute myocardial infarction Cardiac disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hypercholesterolaemia Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Heart rate increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dry mouth Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Tooth infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Blood pressure diastolic increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Insomnia Psychiatric disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Chills General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Constipation Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 otitis media Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Rash maculo-papular Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hand fracture Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Ear canal abrasion Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dysaesthesia Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Oral infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Depressed level of consciousness Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Rash pruritic Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Syncope Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Thermal burn Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Fatigue General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Malaise General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Oropharyngeal pain Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Periodontitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Neck pain Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Sinus congestion Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Diverticulum Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pyelonephritis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Ovarian cyst Reproductive system and breast disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Body tinea Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Secretion discharge General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 sinus headache Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Haemoptysis Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Chest pain General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dyspnoea Respiratory, thoracic and mediastinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Parotitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Blood pressure increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Ejaculation failure Reproductive system and breast disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Vitamin D deficiency Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Mouth ulceration Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Post-traumatic neck syndrome Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Gastroenteritis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pharyngitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Conjunctivitis Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dehydration Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Ligament rupture Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Rash pustular Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Increased appetite Metabolism and nutrition disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Ligament sprain Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Arthropod bite Injury, poisoning and procedural complications MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Groin pain Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Limb discomfort Musculoskeletal and connective tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Nervousness Psychiatric disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Memory impairment Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Semen volume decreased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Libido decreased Psychiatric disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Testicular pain Reproductive system and breast disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Feeling hot General disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Viral infection Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Ecchymosis Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hypotension Vascular disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Aphasia Nervous system disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Oesophagitis Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Pancreatic atrophy Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hepatomegaly Hepatobiliary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Barrett's oesophagus Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Oesophageal stenosis Gastrointestinal disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Hot flash Vascular disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Low density lipoprotein increased Investigations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Gastroenteritis viral Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Dermal cyst Skin and subcutaneous tissue disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Prostatitis Reproductive system and breast disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Oral herpes Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Tinea manuum Infections and infestations MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Nephrolithiasis Renal and urinary disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Buried penis syndrome Congenital, familial and genetic disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003 Benign prostatic hyperplasia Reproductive system and breast disorders MedDRA (21.1) Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 3 at risk EG002 0 events 0 affected 9 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? Yes
Title Organization Phone Extension Email Dr. Peter Traber Selecta Biosciences, Inc. 713-540-9776 ptraber@selectabiosciences.com
SAP No Yes No Statistical Analysis Plan Feb 12, 2019 Apr 1, 2021
ID Term D033461 Hyperuricemia
ID Term D010335 Pathologic Processes D013568 Pathological Conditions, Signs and Symptoms
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BG007 0
BG008 0
BG009 0
BG010 0
BG011 0
BG012 0
BG013 0
BG014 0 Asian BG000 0 BG001 0 BG002 0 BG003 1 BG004 0 BG005 0 BG006 0 BG007 0 BG008 2 BG009 0 BG010 0 BG011 1 BG012 0 BG013 0 BG014 4
Native Hawaiian or Other Pacific Islander BG000 0 BG001 0 BG002 0 BG003 2 BG004 0 BG005 0 BG006 0 BG007 0 BG008 0 BG009 1 BG010 0 BG011 1 BG012 0 BG013 0 BG014 4
Black or African American BG000 1 BG001 2 BG002 2 BG003 2 BG004 2 BG005 2 BG006 3 BG007 4 BG008 2 BG009 6 BG010 4 BG011 7 BG012 1 BG013 2 BG014 40
White BG000 2 BG001 0 BG002 7 BG003 5 BG004 4 BG005 9 BG006 8 BG007 8 BG008 10 BG009 6 BG010 10 BG011 14 BG012 10 BG013 10 BG014 103
Unknown or Not Reported BG000 0 BG001 1 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0 BG007 0 BG008 0 BG009 0 BG010 0 BG011 0 BG012 0 BG013 0 BG014 1
10
OG004 6
OG005 11
OG006 11
OG007 12
OG008 14
OG009 13
OG010 14
OG011 23
OG012 11
OG013 12 10
OG004 6
OG005 11
OG006 11
OG007 12
OG008 14
OG009 13
OG010 14
OG011 23
OG012 11
OG013 12 SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) + SEL-037 (pegadricase) every 28 days for 5 doses
Title Denominators Categories Treatment Period 3 Treatment Period 5 Title Measurements OG000 NA No subjects in the arm were dosed during treatment period 5 OG001 27 OG002 21
SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.05 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG004 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + SEL-037 (pegadricase) 0.2 mg/kg every 28 days for 3 doses followed by SEL-037 0.2 mg/kg every 28 days for 2 doses
OG005 SEL-212: SEL-110 (0.08 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.08 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG006 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
OG007 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG008 SEL-212: SEL-110 (0.125 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.125 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG009 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 3 Doses Then SEL-037 Low Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 3 doses followed by Pegadricase 0.2 mg/kg every 28 days for 2 doses
OG010 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 High Dose for 3 Doses Then SEL-037 High Dose for 2 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.4 mg/kg every 28 days for 3 doses followed by Pegadricase 0.4 mg/kg every 28 days for 2 doses
OG011 SEL-212: SEL-110 (0.15 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212 - Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
OG012 SEL-212: SEL-110 0.15 mg/kg + SEL-037 Low Dose x 1 Then SEL-110 0.1 mg/kg + SEL-037 Low x 4 Doses SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.15 mg/kg + Pegadricase 0.2 mg/kg x 1 Then SEL-110 0.1 mg/kg + Pegadricase 0.2 mg/kg x 4 Doses
OG013 SEL-212: SEL-110 (0.1 mg/kg) + SEL-037 Low Dose for 5 Doses SEL-212: Combination of SEL-110 (nanoparticle encapsulating rapamycin) 0.1 mg/kg + Pegadricase 0.2 mg/kg every 28 days for 5 doses
Units Counts Participants OG000 2 OG001 1 OG002 6 OG003 5 OG004 6 OG005 8 OG006 10 OG007 10 OG008 8 OG009 9 OG010 11 OG011 18 OG012 6 OG013 8
Title Denominators Categories Treatment Period 3 Title Measurements OG000 0 OG001 0 OG002 2 OG003 1 OG004 4 OG005 6 OG006 7 OG007 7 OG008 7 OG009 8 OG010 9 OG011 12 OG012 5 OG013 6
Treatment Period 5 Title Measurements OG000 NA No subjects in the arm were dosed during treatment period 5 OG001 NA No subjects in the arm were dosed during treatment period 5 OG002 1 OG003
0 events
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10 at risk
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EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
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10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 2 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 2 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
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10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 2 events 1 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 1 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 1 events 1 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 1 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 1 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 2 events 1 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 1 events 1 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 2 events 2 affected 6 at risk
EG005 1 events 1 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 1 events 1 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 1 events 1 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 1 events 1 affected 11 at risk
EG013 0 events 0 affected 12 at risk 1 events
1 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 3 events 2 affected 14 at risk
EG009 2 events 2 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 4 events 4 affected 23 at risk
EG012 5 events 3 affected 11 at risk
EG013 1 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 3 events 3 affected 12 at risk
EG008 4 events 3 affected 14 at risk
EG009 1 events 1 affected 13 at risk
EG010 5 events 4 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 3 events 1 affected 11 at risk
EG013 0 events 0 affected 12 at risk 1 events
1 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 4 events 3 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 3 events 3 affected 23 at risk
EG012 1 events 1 affected 11 at risk
EG013 0 events 0 affected 12 at risk 4 events
4 affected
10 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 11 at risk
EG006 5 events 3 affected 11 at risk
EG007 6 events 3 affected 12 at risk
EG008 5 events 3 affected 14 at risk
EG009 2 events 1 affected 13 at risk
EG010 4 events 3 affected 14 at risk
EG011 8 events 4 affected 23 at risk
EG012 8 events 3 affected 11 at risk
EG013 3 events 3 affected 12 at risk 0 events
0 affected
10 at risk
EG004 2 events 2 affected 6 at risk
EG005 4 events 3 affected 11 at risk
EG006 2 events 1 affected 11 at risk
EG007 4 events 4 affected 12 at risk
EG008 4 events 3 affected 14 at risk
EG009 2 events 1 affected 13 at risk
EG010 3 events 3 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 1 events 1 affected 11 at risk
EG013 2 events 2 affected 12 at risk 0 events
0 affected
10 at risk
EG004 2 events 1 affected 6 at risk
EG005 1 events 1 affected 11 at risk
EG006 2 events 1 affected 11 at risk
EG007 3 events 3 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 3 events 1 affected 13 at risk
EG010 2 events 2 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 2 events 2 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 1 events 1 affected 14 at risk
EG011 3 events 2 affected 23 at risk
EG012 1 events 1 affected 11 at risk
EG013 0 events 0 affected 12 at risk 1 events
1 affected
10 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 3 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 3 events 1 affected 14 at risk
EG011 5 events 2 affected 23 at risk
EG012 2 events 1 affected 11 at risk
EG013 3 events 2 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 2 events 1 affected 14 at risk
EG009 2 events 1 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 1 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 1 events 1 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 1 events 1 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 2 events 2 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 1 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 2 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 2 events 1 affected 14 at risk
EG011 3 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 3 events 1 affected 14 at risk
EG011 3 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 1 events
1 affected
10 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 2 events 1 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 1 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 2 events 2 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 1 events 1 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 1 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 1 events 1 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 1 events 1 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 2 events 1 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 1 events 1 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 1 events 1 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 1 events 1 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 1 events 1 affected 13 at risk
EG010 0 events 0 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 11 at risk
EG006 0 events 0 affected 11 at risk
EG007 0 events 0 affected 12 at risk
EG008 0 events 0 affected 14 at risk
EG009 0 events 0 affected 13 at risk
EG010 1 events 1 affected 14 at risk
EG011 0 events 0 affected 23 at risk
EG012 0 events 0 affected 11 at risk
EG013 0 events 0 affected 12 at risk 0 events
0 affected
10 at risk
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