Study. Human Tolerance of Low Molecular Weight. Polyethylene Markers. Prof. Dr. Dr. Ruprecht Keller. Krankenhaus Merheim Zentrallabor

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1 Study Human Tolerance of Low Molecular Weight Polyethylene Markers Prof. Dr. Dr. Ruprecht Keller Krankenhaus Merheim Zentrallabor Ostmerheimerstr Köln

2 Human Tolerance of Low Molecular Weight Polyethylene Markers page. Composition of the marker The marker is administered as a soft gel with 50 mg each of two monodisperse low molecular weight polyethylene glycols of 8 (mw = 58) and 0 (mw = 8) repeating units, 0,0 g dye brilliant blue and Capmul MCM and Polysorbate 80 as an excipient for a total quantity of 00 mg/soft gel. The soft gel capsule is composed of gelatin. The marker is swallowed under supervision.. Participants of the study The study took place between April th 0 and May 6 th 0 with participants initially. Two participants had to be expelled from the study because they had acquired a severe virus infection while the study was on going. This infection was not related to the intake of marker soft gels. Every participant was asked to give the following information. Data is summarized in Table. Date of birth Name Surname Gender Height Weight Smoker (yes / no, if yes how many cigarettes) Alcohol consumption Known allergies Blood pressure (measured on day and end of the study) Pregnancy (yes / no) Number and age of children Acute diseases present and in the past Chronic diseases present and in the past Medication Known reaction to drugs Known reaction to polyethylene glycols

3 Human Tolerance of Low Molecular Weight Polyethylene Markers page Table : Participant Information Participant Participant Participant Participant Participant 5 Date of Birth Blood pressure 0 / 85 0/85 0 / 85 0 / 85 0/95 Gender Male Female Male Male Female Pregnancy Height 85 cm 80 cm 87 cm 98 cm 67 cm Weight 0 kg 68 kg 90 kg 08 kg 97 kg 0 cigarettes/ 5 cigarettes/ Smoker day day Alcohol consumption Rare Rare Rare Rare Allergy Children Acute diseases/ Surgery Chronic diseases ne Appendectomy, 00 Surgical removal of gall stones, 00 High blood pressure Lung emboli, 0 High blood pressure Medication Amipril, 5 mg Micardis, 80 mg Known reaction to drugs Known reaction to Polyethylene glycol Macrolide antibiotics 0 cigarettes/ day

4 Human Tolerance of Low Molecular Weight Polyethylene Markers page Participant 6 Participant 7 Participant 8 Participant 9 Participant 0 Date of Birth Blood pressure 00/70 60/00 0 / 85 0/80 0/85 Gender Female Female Female Male Female Pregnancy Height 68 cm 70 cm 68 cm 7 cm 68 cm Weight 7 kg 70 kg 80,5 kg 7 kg 7 kg 0 cigarettes / 5 cigarettes / Smoker day day Alcohol consumption Rare Rare Allergy Latex Fruit, Hay fever Penicillin, Nickel Children Acute diseases/ Surgery Chronic diseases Medication Known reaction to drugs Known reaction to Polyethylene glycol C-Section, 005 Streptococcus myocarditis, 99 Knee TEP, 0 C-Section, 007 C-Section, 987 High blood pressure Micardis, 80 mg Amiodipin, 5mg Cymbalta, Iron, Vitamin D

5 Human Tolerance of Low Molecular Weight Polyethylene Markers page 5. Operational and Organizational structure Participants were given soft gel each on the following dates (7 soft gels in total):. th of April 0. th of April 0. 8 th of April 0. 5 th of April 0 5. nd of May th of May th of May 0 Participants were not asked to be sober when blood was collected. Blood samples were drawn after administering the soft gels on the same day on the following dates ( blood collections in total):. th of April 0. 8 th of April 0. nd of May 0. 6 th of May 0 Blood samples were investigated for the following analytes: Heparin plasma o Sodium (=Na) o Potassium (=K) o Glucose (=GLU) o Urea (UREA) o Creatinine (=CREA) o Total protein (=TP o Bilirubin (=BIL) o LDH (LDH) o AST (AST) o ALT (AST) o γ-gt (=GGT) o Alkaline phosphatase (=AP) o HDL (HDL) o Triglycerides (=TRI) o Cholesterol (=CHOL) o C-reactive protein (=CRP) EDTA blood: o Full blood count incl. differentiation of leucocytes

6 Human Tolerance of Low Molecular Weight Polyethylene Markers page 6. Results.. Clinical signs of side reactions to marker soft gels There was no side reaction like nausea, allergic reactions, increase of blood pressure etc. observed in the course of the study... Laboratory investigations There was no significant change of laboratory parameters observed in this study that could be directed to a side reaction to the marker soft gel. Data are summarized in table table.

7 Human Tolerance of Low Molecular Weight Polyethylene Markers page 7 Table : Laboratory data of participant WBC / nl Ery / pl Hemoglobin. -.5 g / dl Hematocrit - % MCV fl MCH 7. - pg MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic % Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 % AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l TP g / dl GGT <0 U / l GLU mg / dl AST <5 U / l ALT <5 U / l 5 HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl TRI <50 mg / dl

8 Human Tolerance of Low Molecular Weight Polyethylene Markers page 8 Table : Laboratory data of participant WBC / nl Ery / pl Hemoglobin. -.5 g / dl Hematocrit - % MCV Fl MCH 7. - Pg MCHC g / dl.... Platelets 0-60 / nl Basophilic <.5 % Eosinophilic % Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 % AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l <.0 <.0 <.0 <.0 TP g / dl GGT <0 U / l 0 0 GLU mg / dl AST <5 U / l 0 ALT <5 U / l 6 6 HDL >0 mg / dl UREA 5 0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl 9 TRI <50 mg / dl

9 Human Tolerance of Low Molecular Weight Polyethylene Markers page 9 Table : Laboratory data of participant WBC / nl Ery / pl..0.. Hemoglobin. -.5 g / dl....8 Hematocrit - % MCV fl MCH 7. - pg...0. MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic % Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 % AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l <.0 <.0 <.0 <.0 TP g / dl GGT <0 U / l GLU mg / dl AST <5 U / l ALT <5 U / l HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl TRI <50 mg / dl

10 Human Tolerance of Low Molecular Weight Polyethylene Markers page 0 Table 5: Laboratory data of participant WBC / nl Ery / pl Hemoglobin. -.5 g / dl Hematocrit - % MCV fl MCH 7. - pg MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic %...6. Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 %...0. AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l TP g / dl GGT <0 U / l GLU mg / dl AST <5 U / l ALT <5 U / l HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl 8 8 TRI <50 mg / dl 95 80

11 Human Tolerance of Low Molecular Weight Polyethylene Markers page Table 6: Laboratory data of participant 5 WBC / nl Ery / pl Hemoglobin. -.5 g / dl Hematocrit - % MCV fl MCH 7. - pg MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic %.... Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 %.... AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l <.0 <.0 <.0 <.0 TP g / dl GGT <0 U / l 0 8 GLU mg / dl AST <5 U / l 5 ALT <5 U / l HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl TRI <50 mg / dl

12 Human Tolerance of Low Molecular Weight Polyethylene Markers page Table 7: Laboratory data of participant 6 WBC / nl Ery / pl...5. Hemoglobin. -.5 g / dl Hematocrit - % MCV fl MCH 7. - pg MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic % Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 %..0.7 AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l <.0 <.0 <.0 <.0 TP g / dl GGT <0 U / l GLU mg / dl AST <5 U / l ALT <5 U / l HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl TRI <50 mg / dl

13 Human Tolerance of Low Molecular Weight Polyethylene Markers page Table 8: Laboratory data of participant 7 WBC / nl Ery / pl Hemoglobin. -.5 g / dl...0. Hematocrit - % MCV fl MCH 7. - pg MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic % Neutrophilic % Lympho % Mono.6-8. %....0 Large unstained cells <.5 % AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l <.0 <.0 <.0 <.0 TP g / dl GGT <0 U / l 6 5 GLU mg / dl AST <5 U / l 0 9 ALT <5 U / l HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl TRI <50 mg / dl

14 Human Tolerance of Low Molecular Weight Polyethylene Markers page Table 9: Laboratory data of participant 8 WBC / nl Ery / pl Hemoglobin. -.5 g / dl Hematocrit - % MCV Fl MCH 7. - Pg MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic % Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 % AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l <.0 <.0 <.0 <.0 TP g / dl GGT <0 U / l 6 7 GLU mg / dl AST <5 U / l 6 ALT <5 U / l HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl TRI <50 mg / dl

15 Human Tolerance of Low Molecular Weight Polyethylene Markers page 5 Table 0: Laboratory data of participant 9 WBC / nl Ery / pl Hemoglobin. -.5 g / dl Hematocrit - % MCV fl MCH 7. - pg MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic % Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 % AP U / l BIL mg / dl CHOL <90 mg / dl CRP <.0 mg / l <0. <.0 <.0 <.0 TP g / dl GGT <0 U / l GLU mg / dl AST <5 U / l 7 8 ALT <5 U / l HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl.5... LDH <50 U / l NA 5-5 mg / dl TRI <50 mg / dl

16 Human Tolerance of Low Molecular Weight Polyethylene Markers page 6 Table : Laboratory data of participant 0 WBC / nl Ery / pl Hemoglobin. -.5 g / dl Hematocrit - % MCV fl MCH 7. - pg MCHC g / dl Platelets 0-60 / nl Basophilic <.5 % Eosinophilic % Neutrophilic % Lympho % Mono.6-8. % Large unstained cells <.5 % AP U / l BIL mg / dl CHOL <90 mg / dl 0 CRP <.0 mg / l <.0 <.0 <.0 <.0 TP g / dl GGT <0 U / l 0 GLU mg / dl AST <5 U / l ALT <5 U / l HDL >0 mg / dl UREA 5-0 mg / dl K mg / dl CREA mg / dl LDH <50 U / l NA 5-5 mg / dl TRI <50 mg / dl