ID

44215

Beschreibung

Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00433108

Link

https://clinicaltrials.gov/show/NCT00433108

Stichworte

Versionen (2)
  1. 03.12.17 03.12.17 -
  2. 20.09.21 20.09.21 -
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See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Eligibility Chronic Hepatitis C NCT00433108

Englisch

Eligibility Chronic Hepatitis C NCT00433108

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. willing to adhere to study requirements as evidenced by providing written informed consent before initiation of any study-related procedures
Beschreibung

Protocol Compliance | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
2. aged between 18-65 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. documented history of chronic hcv infection (for at least 6 months prior to study entry) as diagnosed by either:
Beschreibung

Chronic Hepatitis C Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0872146
1. anti-hcv positive or
Beschreibung

Hepatitis C antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0281863
2. hcv rna viral load positive by pcr
Beschreibung

Hepatitis C RNA positive Polymerase Chain Reaction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0855842
UMLS CUI [1,2]
C0032520
4. be a non-responder to or unsuitable for interferon based therapy.
Beschreibung

Interferon therapy Unresponsive to Treatment | Patient Inappropriate Interferon therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279030
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548788
UMLS CUI [2,3]
C0279030
5. have liver inflammation, as defined by either ast and/or alt levels 2-10 x uln on at least 1 previous occasion within the past 6 months and at pre-treatment visit
Beschreibung

Hepatitis | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
6. alpha-fetoprotein (afp) less than/equal to 50µg/l
Beschreibung

Alpha-fetoprotein measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201539
7. hemoglobin ≥100g/l, platelet count ≥75x109/l, and white blood cell count ≥1.5x109/l
Beschreibung

Hemoglobin measurement | Platelet Count measurement | White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0023508
8. males, or females who are not of child-bearing potential or who are taking adequate contraceptive measures. female patients must be postmenopausal for at least 2 years prior to the study, surgically sterile, or using effective contraception for at least 2 months prior to starting study drug and until 28 days following the last dose of study drug. acceptable methods of birth control include hormonal contraceptives, or double-barrier methods.negative serum pregnancy test must be documented at the pre-treatment visit (i.e. within 14 days of starting study drug)
Beschreibung

Gender | Childbearing Potential Absent | Childbearing Potential Contraceptive methods | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Hormonal contraception | Barrier Contraception Double | Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0015787
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0700589
UMLS CUI [7]
C2985296
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9]
C0427780
9. liver biopsy within past 3 years showing stage 2 fibrosis only (i.e. excludes cirrhosis and cancer); or within past 6 years showing stage 0 or 1 (no or minimal scarring).
Beschreibung

Fibrosis stage Biopsy of liver | Liver Cirrhosis Excluded | Malignant Neoplasms Excluded | Minimal or absent scarring

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016059
UMLS CUI [1,2]
C0699749
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C2828389
UMLS CUI [4]
C1856942
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hepatocellular carcinoma (hcc) or suspicion of hcc clinically or on ultrasound (or other imaging techniques)
Beschreibung

Liver carcinoma | Suspicion Liver carcinoma | Liver carcinoma Ultrasonography | Suspicion Liver carcinoma Ultrasonography | Liver carcinoma Imaging Technique | Suspicion Liver carcinoma Imaging Technique

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0242114
UMLS CUI [2,2]
C2239176
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0041618
UMLS CUI [4,1]
C0242114
UMLS CUI [4,2]
C2239176
UMLS CUI [4,3]
C0041618
UMLS CUI [5,1]
C2239176
UMLS CUI [5,2]
C0079595
UMLS CUI [6,1]
C0242114
UMLS CUI [6,2]
C2239176
UMLS CUI [6,3]
C0079595
2. presence of human immunodeficiency virus (hiv)
Beschreibung

HIV Presence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0150312
3. co-infection with hepatitis b virus (hbv)
Beschreibung

HBV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C2242656
4. last baseline ast and alt level prior to day 1 of <2.0xuln
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
5. renal impairment (creatinine>1.5 x uln) or hepatorenal syndrome
Beschreibung

Renal Insufficiency | Serum creatinine raised | Hepatorenal Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
UMLS CUI [3]
C0019212
6. chronic pancreatitis
Beschreibung

Pancreatitis, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0149521
7. hospitalization for liver disease within 60 days of the pre-treatment visit
Beschreibung

Hospitalization Liver disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0023895
8. liver transplant recipients
Beschreibung

Liver transplant recipient

Datentyp

boolean

Alias
UMLS CUI [1]
C3811922
9. use of drug therapy for hepatitis c, including the use of:
Beschreibung

Pharmacotherapy Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0019196
1. drugs with presumed anti-hepatitis c activity in the past 3 months
Beschreibung

Pharmaceutical Preparations Activity Against Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0521124
UMLS CUI [1,4]
C0019196
2. corticosteroids in the past 30 days
Beschreibung

Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0001617
3. drugs with medium to high risk of hepatotoxicity (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin) in the past 30 days
Beschreibung

Pharmaceutical Preparations Hepatotoxicity Risk Moderate | Pharmaceutical Preparations Hepatotoxicity High risk | Methyldopa | Valproic Acid | isoniazid | Nitrofurantoin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0235378
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C0205081
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0235378
UMLS CUI [2,3]
C0332167
UMLS CUI [3]
C0025741
UMLS CUI [4]
C0042291
UMLS CUI [5]
C0022209
UMLS CUI [6]
C0028156
10. any patient who admits to using or has a positive screening test for: amphetamines, barbiturates, pethidine, benzodiazepine, cocaine, methadone, opiates, phencyclidine or propoxyphene (unless medically prescribed and in stable doses for at least 30 days)
Beschreibung

Amphetamines | Barbiturates | Meperidine | Benzodiazepines | Cocaine | Methadone | Opiates | Phencyclidine | Propoxyphene

Datentyp

boolean

Alias
UMLS CUI [1]
C0002667
UMLS CUI [2]
C0004745
UMLS CUI [3]
C0025376
UMLS CUI [4]
C0005064
UMLS CUI [5]
C0009170
UMLS CUI [6]
C0025605
UMLS CUI [7]
C0376196
UMLS CUI [8]
C0031381
UMLS CUI [9]
C0033493
11. alcohol consumption >5 units per week
Beschreibung

Alcohol consumption U/week

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560588
12. any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial
Beschreibung

Investigational New Drugs | Investigational Medical Device | Investigational New Drugs Scheduled | Investigational Medical Device Scheduled

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0205539
UMLS CUI [4,1]
C2346570
UMLS CUI [4,2]
C0205539
13. history of a malignancy other than treated basal cell or squamous cell carcinoma of the skin; those with a history of malignancy that has been treated with no recurrence within the last 2 years are not excluded
Beschreibung

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
14. use of antioxidants (coenzyme q10 and idebenone) at doses ≥300mg/day within 120 days prior to enrolment. doses between 25-300mg/day are not an exclusion and require a 7 day washout prior to study enrolment
Beschreibung

Antioxidants U/day | coenzyme Q10 | idebenone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003402
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0041536
UMLS CUI [3]
C0123163
15. use of dietary supplements (vitamin or mineral) at constant doses throughout the study (unless medically prescribed). patients choosing to stop using supplements are not excluded and require a 7 day washout period prior to study enrolment
Beschreibung

Dietary Supplements Dose Constant | Vitamin supplement | Mineral supplements

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242295
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1948059
UMLS CUI [2]
C0681579
UMLS CUI [3]
C0556112
16. history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including coenzyme q10 and idebenone
Beschreibung

Hypersensitivity Investigational New Drugs Component | Hypersensitivity Compound Similar | Hypersensitivity coenzyme Q10 | Hypersensitivity idebenone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C2348205
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0041536
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0123163
17. unable to swallow tablets whole.
Beschreibung

Lacking Able to swallow Tablets

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
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Ähnliche Modelle

Eligibility Chronic Hepatitis C NCT00433108

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance | Informed Consent
Item
1. willing to adhere to study requirements as evidenced by providing written informed consent before initiation of any study-related procedures
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Age
Item
2. aged between 18-65 years
boolean
C0001779 (UMLS CUI [1])
Chronic Hepatitis C Disease length
Item
3. documented history of chronic hcv infection (for at least 6 months prior to study entry) as diagnosed by either:
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hepatitis C antibody positive
Item
1. anti-hcv positive or
boolean
C0281863 (UMLS CUI [1])
Hepatitis C RNA positive Polymerase Chain Reaction
Item
2. hcv rna viral load positive by pcr
boolean
C0855842 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
Interferon therapy Unresponsive to Treatment | Patient Inappropriate Interferon therapy
Item
4. be a non-responder to or unsuitable for interferon based therapy.
boolean
C0279030 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
C0279030 (UMLS CUI [2,3])
Hepatitis | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
5. have liver inflammation, as defined by either ast and/or alt levels 2-10 x uln on at least 1 previous occasion within the past 6 months and at pre-treatment visit
boolean
C0019158 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Alpha-fetoprotein measurement
Item
6. alpha-fetoprotein (afp) less than/equal to 50µg/l
boolean
C0201539 (UMLS CUI [1])
Hemoglobin measurement | Platelet Count measurement | White Blood Cell Count procedure
Item
7. hemoglobin ≥100g/l, platelet count ≥75x109/l, and white blood cell count ≥1.5x109/l
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
Gender | Childbearing Potential Absent | Childbearing Potential Contraceptive methods | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Hormonal contraception | Barrier Contraception Double | Pregnancy test negative
Item
8. males, or females who are not of child-bearing potential or who are taking adequate contraceptive measures. female patients must be postmenopausal for at least 2 years prior to the study, surgically sterile, or using effective contraception for at least 2 months prior to starting study drug and until 28 days following the last dose of study drug. acceptable methods of birth control include hormonal contraceptives, or double-barrier methods.negative serum pregnancy test must be documented at the pre-treatment visit (i.e. within 14 days of starting study drug)
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0015787 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C2985296 (UMLS CUI [7])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0427780 (UMLS CUI [9])
Fibrosis stage Biopsy of liver | Liver Cirrhosis Excluded | Malignant Neoplasms Excluded | Minimal or absent scarring
Item
9. liver biopsy within past 3 years showing stage 2 fibrosis only (i.e. excludes cirrhosis and cancer); or within past 6 years showing stage 0 or 1 (no or minimal scarring).
boolean
C0016059 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0023890 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C1856942 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Liver carcinoma | Suspicion Liver carcinoma | Liver carcinoma Ultrasonography | Suspicion Liver carcinoma Ultrasonography | Liver carcinoma Imaging Technique | Suspicion Liver carcinoma Imaging Technique
Item
1. hepatocellular carcinoma (hcc) or suspicion of hcc clinically or on ultrasound (or other imaging techniques)
boolean
C2239176 (UMLS CUI [1])
C0242114 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0242114 (UMLS CUI [4,1])
C2239176 (UMLS CUI [4,2])
C0041618 (UMLS CUI [4,3])
C2239176 (UMLS CUI [5,1])
C0079595 (UMLS CUI [5,2])
C0242114 (UMLS CUI [6,1])
C2239176 (UMLS CUI [6,2])
C0079595 (UMLS CUI [6,3])
HIV Presence
Item
2. presence of human immunodeficiency virus (hiv)
boolean
C0019682 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
HBV coinfection
Item
3. co-infection with hepatitis b virus (hbv)
boolean
C2242656 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
4. last baseline ast and alt level prior to day 1 of <2.0xuln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Renal Insufficiency | Serum creatinine raised | Hepatorenal Syndrome
Item
5. renal impairment (creatinine>1.5 x uln) or hepatorenal syndrome
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0019212 (UMLS CUI [3])
Pancreatitis, Chronic
Item
6. chronic pancreatitis
boolean
C0149521 (UMLS CUI [1])
Hospitalization Liver disease
Item
7. hospitalization for liver disease within 60 days of the pre-treatment visit
boolean
C0019993 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Liver transplant recipient
Item
8. liver transplant recipients
boolean
C3811922 (UMLS CUI [1])
Pharmacotherapy Hepatitis C
Item
9. use of drug therapy for hepatitis c, including the use of:
boolean
C0013216 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Pharmaceutical Preparations Activity Against Hepatitis C
Item
1. drugs with presumed anti-hepatitis c activity in the past 3 months
boolean
C0013227 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0521124 (UMLS CUI [1,3])
C0019196 (UMLS CUI [1,4])
Adrenal Cortex Hormones
Item
2. corticosteroids in the past 30 days
boolean
C0001617 (UMLS CUI [1])
Pharmaceutical Preparations Hepatotoxicity Risk Moderate | Pharmaceutical Preparations Hepatotoxicity High risk | Methyldopa | Valproic Acid | isoniazid | Nitrofurantoin
Item
3. drugs with medium to high risk of hepatotoxicity (including alpha methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin) in the past 30 days
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C0205081 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0235378 (UMLS CUI [2,2])
C0332167 (UMLS CUI [2,3])
C0025741 (UMLS CUI [3])
C0042291 (UMLS CUI [4])
C0022209 (UMLS CUI [5])
C0028156 (UMLS CUI [6])
Amphetamines | Barbiturates | Meperidine | Benzodiazepines | Cocaine | Methadone | Opiates | Phencyclidine | Propoxyphene
Item
10. any patient who admits to using or has a positive screening test for: amphetamines, barbiturates, pethidine, benzodiazepine, cocaine, methadone, opiates, phencyclidine or propoxyphene (unless medically prescribed and in stable doses for at least 30 days)
boolean
C0002667 (UMLS CUI [1])
C0004745 (UMLS CUI [2])
C0025376 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0009170 (UMLS CUI [5])
C0025605 (UMLS CUI [6])
C0376196 (UMLS CUI [7])
C0031381 (UMLS CUI [8])
C0033493 (UMLS CUI [9])
Alcohol consumption U/week
Item
11. alcohol consumption >5 units per week
boolean
C0001948 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
Investigational New Drugs | Investigational Medical Device | Investigational New Drugs Scheduled | Investigational Medical Device Scheduled
Item
12. any patient who has received any investigational drug or device within 30 days of dosing, or who is scheduled to receive another investigational drug or device during the course of this trial
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C2346570 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
13. history of a malignancy other than treated basal cell or squamous cell carcinoma of the skin; those with a history of malignancy that has been treated with no recurrence within the last 2 years are not excluded
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Antioxidants U/day | coenzyme Q10 | idebenone
Item
14. use of antioxidants (coenzyme q10 and idebenone) at doses ≥300mg/day within 120 days prior to enrolment. doses between 25-300mg/day are not an exclusion and require a 7 day washout prior to study enrolment
boolean
C0003402 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0041536 (UMLS CUI [2])
C0123163 (UMLS CUI [3])
Dietary Supplements Dose Constant | Vitamin supplement | Mineral supplements
Item
15. use of dietary supplements (vitamin or mineral) at constant doses throughout the study (unless medically prescribed). patients choosing to stop using supplements are not excluded and require a 7 day washout period prior to study enrolment
boolean
C0242295 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1948059 (UMLS CUI [1,3])
C0681579 (UMLS CUI [2])
C0556112 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs Component | Hypersensitivity Compound Similar | Hypersensitivity coenzyme Q10 | Hypersensitivity idebenone
Item
16. history of a hypersensitivity reaction to any components of the study drug or structurally similar compounds including coenzyme q10 and idebenone
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0041536 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0123163 (UMLS CUI [4,2])
Lacking Able to swallow Tablets
Item
17. unable to swallow tablets whole.
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
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