Inglês

The data table (n=12 variables) contains information about the occurrence of adverse events during the AREDS clinical trial, e.g. type of adverse event, severity, primary ICD9 code, outcome, potential relationship to study drug, timing, and treatment. Data were collected through the clinical trial and for the first 6 months of the natural history follow-up immediately after the clinical trial concluded. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.

19 Formulários  
  1. StudyEvent: NEI Age-Related Eye Disease Study (AREDS)
    1. Eligibility Criteria
    2. The data table (n=142 variables) contains AMD and cataract phenotype information, medical history and socio-demographic information drawn from several data sets (e.g. enrollment_randomization, amdlensphenotype, followup), plus a unique patient identifier (ID2) for participants with a genetic specimen (to be found only in GENSPECPHENOTYPE and GENSPECFUNDUSLENS [pht000376] tables). Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Other disease information (e.g. diabetes, cancer, angina), medical information (e.g. BMI, blood pressure) and smoking status are also included annually throughout follow-up.
    3. The data table (n=12 variables) contains information about the occurrence of adverse events during the AREDS clinical trial, e.g. type of adverse event, severity, primary ICD9 code, outcome, potential relationship to study drug, timing, and treatment. Data were collected through the clinical trial and for the first 6 months of the natural history follow-up immediately after the clinical trial concluded. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    4. The data table (n=25 variables) contains detailed information about cataract phenotypes (n=23 variables) as well as final AMD phenotype (n=1 variable), and patient ID. Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    5. The data table (n=56 variables) contains information about AREDS participants' dietary intake of alcohol, amino acids, carbohydrates, fiber, poly- and monounsaturated fatty acids, proteins, vitamins and minerals. Participants' glycemic index and glycemic load are also included. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    6. The data table (n=102 variables) contains AREDS treatment assignment, basic socio-demographic characteristics and baseline medical history for AREDS participants. Medical history information includes eye disease information such as AMD Category, visual acuity, and past ophthalmic treatments (e.g. cataract surgery, laser treatment), as well as information about the presence/absence of other diseases (e.g. angina, arthritis, cancer, diabetes, high blood pressure), use of prescribed drugs for disease management (e.g. blood-thinning medications, digoxin, thyroid hormones, insulin), use of over-the-counter drugs (e.g. NSAIDs, antacids), intake of vitamins and minerals, and smoking history. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    7. The data table (n=83 variables) contains information obtained at follow-up visits during the AREDS clinical trial (every six months following randomization), annually in person during the natural history follow-up, and via phone between annual in-person visits. Variables include information about AREDS participants' ophthalmic medical history (e.g. cataract or other eye surgery, laser treatment for AMD, retinal repair, capsulotomy, presence/absence of lens, glaucoma, and visual acuity) and general medical information, including new diagnoses of cancer, heart disease, stroke, and peripheral vascular disease, disease history of angina and high blood pressure, current disease status of diabetes, arthritis, and gout, use of prescribed drugs for disease treatment or management (e.g. blood-thinning medications, digoxin, thyroid hormones, insulin), use of over-the-counter drugs (e.g. NSAIDs, antacids), and smoking behavior. For version 3 release of the study, visual acuity data of the right eye have been added for odd-numbered visits. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    8. The data table (n=49 variables) contains information from AREDS participants' fundus photographs, including presence, type, and extent of drusen, presence/extent of RPE depigmentation, SSR (serous sensory retinal) detachments, subretinal hemorrhages, subretinal fibrosis, and geographic atrophy. In addition, information on photocoagulation (PC) treatment for AMD SRNV is included, as well as AMD Severity Scale Scores and AMD Simple Scale Scores calculated from the fundus data. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    9. The data table (n=62) contains information only for AREDS participants who have a genetic specimen. A unique patient identifier (ID2 field) for these participants (to be found only in GENSPECPHENOTYPE [pht000001.v2.p1] and GENSPECFUNDUSLENS data tables) is included instead of the patient identifier used for data tables with all participants (ID field). Information about fundus and lens characteristics are included as follows - fundus: presence, type, and extent of drusen, presence/extent of RPE depigmentation, SSR (serous sensory retinal) detachments, subretinal hemorrhages, subretinal fibrosis, and geographic atrophy; lens: degree of nuclear sclerosis, cortical and posterior subcapsular opacities, and iris pigmentation. In addition, information on photocoagulation (PC) treatment for AMD is included as well as AMD Severity Scale Scores and AMD Simple Scale Scores calculated from the fundus data.
    10. The data table (n=6 variables) contains information about AREDS participant hospitalizations (e.g. reason, time from randomization, duration, primary ICD9 code) during the entire study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    11. The data table (n=21 variables) contains information from AREDS participants' lens photographs, including degree of nuclear sclerosis, cortical and posterior subcapsular opacities, and iris pigmentation. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    12. The data table (n=7 variables) contains information about AREDS participant deaths (e.g. cause, time from randomization) during the entire study. A search using the National Death Index (NDI) yielded additional deaths not identified during the study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    13. The data table (n=44 variables) contains information about AREDS participants' use (e.g. type, frequency, dose, duration) of non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen, acetaminophen, naproxen). Data were collected at in-clinic visits starting in October 2004. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    14. The data table (n=16 variables) contains information about AREDS participants' general vision status (e.g. general vision score, ocular pain score, VFQ overall score), and its effect on participants' behavior (e.g. near and distant activities, social activities, driving, mental health score) as obtained through the VFQ-25 questionnaire. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    15. Subject - Consent Information
    16. Subject - Sample Mapping (including mapping to Coriell IDs)
    17. The data table (n=2 variables) contains information on subjects' annual exposure to sunlight (hours; April through September).
    18. This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
    19. This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
pht000370
Descrição

pht000370

DUMMY ID NUMBER
Descrição

ID2

Tipo de dados

string

Alias
UMLS CUI [1,1]
C2348585
IF OTHER, KIDNEY STONES, CARDIOVASCULAR, OR MALIGNANCY, SPECIFY ADVERSE EXPERIENCE DESCRIPTION (ALL PARTICIPANTS)
Descrição

ADVDESC

Tipo de dados

string

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
UMLS CUI [2,1]
C0022650
UMLS CUI [2,2]
C0007222
UMLS CUI [2,3]
C0006826
UMLS CUI [2,4]
C0205394
UMLS CUI [3,1]
C0681850
UMLS CUI [3,2]
C0444868
ADVERSE EXPERIENCE STATUS (ALL PARTICIPANTS)
Descrição

ADVSTAT

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449438
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
SEVERITY (ALL PARTICIPANTS)
Descrição

SEVERITY

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0439793
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
RELATIONSHIP TO STUDY DRUG (ALL PARTICIPANTS)
Descrição

DRUGREL

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
MEDICAL TREATMENT REQUIRED (ALL PARTICIPANTS)
Descrição

TREATMNT

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
IF OTHER, SPECIFY MEDICAL TREATMENT (ALL PARTICIPANTS)
Descrição

TREATSP

Tipo de dados

string

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1521902
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
OUTCOME OF AE (ALL PARTICIPANTS)
Descrição

OUTCOME

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
PRIMARY ICD9 CODE (ALL PARTICIPANTS)
Descrição

ICD9COD1

Tipo de dados

float

Alias
UMLS CUI [1,1]
C0205225
UMLS CUI [1,2]
C2598420
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
TYPE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
Descrição

ADVTYPE

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
YEARS FROM RANDOMIZATION TO DATE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
Descrição

OBSTIME

Tipo de dados

float

Unidades de medida
  • years
Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0877248
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
years
DAYS FROM ADVERSE EXPERIENCE OBSERVE DATE TO DATE OF RESOLUTION (ALL PARTICIPANTS)
Descrição

ADVTIME

Tipo de dados

text

Unidades de medida
  • days
Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3176356
UMLS CUI [1,4]
C2985918
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0444868
days
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The data table (n=12 variables) contains information about the occurrence of adverse events during the AREDS clinical trial, e.g. type of adverse event, severity, primary ICD9 code, outcome, potential relationship to study drug, timing, and treatment. Data were collected through the clinical trial and for the first 6 months of the natural history follow-up immediately after the clinical trial concluded. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.

19 Formulários
  1. StudyEvent: NEI Age-Related Eye Disease Study (AREDS)
    1. Eligibility Criteria
    2. The data table (n=142 variables) contains AMD and cataract phenotype information, medical history and socio-demographic information drawn from several data sets (e.g. enrollment_randomization, amdlensphenotype, followup), plus a unique patient identifier (ID2) for participants with a genetic specimen (to be found only in GENSPECPHENOTYPE and GENSPECFUNDUSLENS [pht000376] tables). Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Other disease information (e.g. diabetes, cancer, angina), medical information (e.g. BMI, blood pressure) and smoking status are also included annually throughout follow-up.
    3. The data table (n=12 variables) contains information about the occurrence of adverse events during the AREDS clinical trial, e.g. type of adverse event, severity, primary ICD9 code, outcome, potential relationship to study drug, timing, and treatment. Data were collected through the clinical trial and for the first 6 months of the natural history follow-up immediately after the clinical trial concluded. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    4. The data table (n=25 variables) contains detailed information about cataract phenotypes (n=23 variables) as well as final AMD phenotype (n=1 variable), and patient ID. Nuclear, cortical and posterior subcapsular opacity information is included for both eyes at baseline and end of study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    5. The data table (n=56 variables) contains information about AREDS participants' dietary intake of alcohol, amino acids, carbohydrates, fiber, poly- and monounsaturated fatty acids, proteins, vitamins and minerals. Participants' glycemic index and glycemic load are also included. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    6. The data table (n=102 variables) contains AREDS treatment assignment, basic socio-demographic characteristics and baseline medical history for AREDS participants. Medical history information includes eye disease information such as AMD Category, visual acuity, and past ophthalmic treatments (e.g. cataract surgery, laser treatment), as well as information about the presence/absence of other diseases (e.g. angina, arthritis, cancer, diabetes, high blood pressure), use of prescribed drugs for disease management (e.g. blood-thinning medications, digoxin, thyroid hormones, insulin), use of over-the-counter drugs (e.g. NSAIDs, antacids), intake of vitamins and minerals, and smoking history. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    7. The data table (n=83 variables) contains information obtained at follow-up visits during the AREDS clinical trial (every six months following randomization), annually in person during the natural history follow-up, and via phone between annual in-person visits. Variables include information about AREDS participants' ophthalmic medical history (e.g. cataract or other eye surgery, laser treatment for AMD, retinal repair, capsulotomy, presence/absence of lens, glaucoma, and visual acuity) and general medical information, including new diagnoses of cancer, heart disease, stroke, and peripheral vascular disease, disease history of angina and high blood pressure, current disease status of diabetes, arthritis, and gout, use of prescribed drugs for disease treatment or management (e.g. blood-thinning medications, digoxin, thyroid hormones, insulin), use of over-the-counter drugs (e.g. NSAIDs, antacids), and smoking behavior. For version 3 release of the study, visual acuity data of the right eye have been added for odd-numbered visits. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    8. The data table (n=49 variables) contains information from AREDS participants' fundus photographs, including presence, type, and extent of drusen, presence/extent of RPE depigmentation, SSR (serous sensory retinal) detachments, subretinal hemorrhages, subretinal fibrosis, and geographic atrophy. In addition, information on photocoagulation (PC) treatment for AMD SRNV is included, as well as AMD Severity Scale Scores and AMD Simple Scale Scores calculated from the fundus data. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    9. The data table (n=62) contains information only for AREDS participants who have a genetic specimen. A unique patient identifier (ID2 field) for these participants (to be found only in GENSPECPHENOTYPE [pht000001.v2.p1] and GENSPECFUNDUSLENS data tables) is included instead of the patient identifier used for data tables with all participants (ID field). Information about fundus and lens characteristics are included as follows - fundus: presence, type, and extent of drusen, presence/extent of RPE depigmentation, SSR (serous sensory retinal) detachments, subretinal hemorrhages, subretinal fibrosis, and geographic atrophy; lens: degree of nuclear sclerosis, cortical and posterior subcapsular opacities, and iris pigmentation. In addition, information on photocoagulation (PC) treatment for AMD is included as well as AMD Severity Scale Scores and AMD Simple Scale Scores calculated from the fundus data.
    10. The data table (n=6 variables) contains information about AREDS participant hospitalizations (e.g. reason, time from randomization, duration, primary ICD9 code) during the entire study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    11. The data table (n=21 variables) contains information from AREDS participants' lens photographs, including degree of nuclear sclerosis, cortical and posterior subcapsular opacities, and iris pigmentation. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    12. The data table (n=7 variables) contains information about AREDS participant deaths (e.g. cause, time from randomization) during the entire study. A search using the National Death Index (NDI) yielded additional deaths not identified during the study. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    13. The data table (n=44 variables) contains information about AREDS participants' use (e.g. type, frequency, dose, duration) of non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen, acetaminophen, naproxen). Data were collected at in-clinic visits starting in October 2004. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    14. The data table (n=16 variables) contains information about AREDS participants' general vision status (e.g. general vision score, ocular pain score, VFQ overall score), and its effect on participants' behavior (e.g. near and distant activities, social activities, driving, mental health score) as obtained through the VFQ-25 questionnaire. Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    15. Subject - Consent Information
    16. Subject - Sample Mapping (including mapping to Coriell IDs)
    17. The data table (n=2 variables) contains information on subjects' annual exposure to sunlight (hours; April through September).
    18. This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
    19. This dataset provides refractive error values obtained from control subjects of the AREDS study (phs000001.v3.p1) and represents a substudy of AREDS ; data of n=7 new variables are provided in addition to basic sociodemographic data. Subject - consent and subject - sample mapping information is available through phs000001.v3.p1.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
pht000370
ID2
Item
DUMMY ID NUMBER
string
C2348585 (UMLS CUI [1,1])
ADVDESC
Item
IF OTHER, KIDNEY STONES, CARDIOVASCULAR, OR MALIGNANCY, SPECIFY ADVERSE EXPERIENCE DESCRIPTION (ALL PARTICIPANTS)
string
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0022650 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
C0681850 (UMLS CUI [3,1])
C0444868 (UMLS CUI [3,2])
Item
ADVERSE EXPERIENCE STATUS (ALL PARTICIPANTS)
text
C0877248 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
ADVSTAT
Code List
ADVERSE EXPERIENCE STATUS (ALL PARTICIPANTS)
CL Item
New (1)
C0205314 (UMLS CUI [1,1])
CL Item
Recurrence (2)
C0034897 (UMLS CUI [1,1])
CL Item
Increased severity (3)
C0205217 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Item
SEVERITY (ALL PARTICIPANTS)
text
C0439793 (UMLS CUI [1,1])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
SEVERITY
Code List
SEVERITY (ALL PARTICIPANTS)
CL Item
Mild (1)
C2945599 (UMLS CUI [1,1])
CL Item
Moderate (2)
C0205081 (UMLS CUI [1,1])
CL Item
Severe (3)
C0205082 (UMLS CUI [1,1])
CL Item
Life-threatening (4)
C2826244 (UMLS CUI [1,1])
Item
RELATIONSHIP TO STUDY DRUG (ALL PARTICIPANTS)
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
DRUGREL
Code List
RELATIONSHIP TO STUDY DRUG (ALL PARTICIPANTS)
CL Item
Probably no (1)
C0750492 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
CL Item
Unable to judge (2)
C1299582 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
CL Item
Probably yes (3)
C0750492 (UMLS CUI [1,1])
C1705108 (UMLS CUI [1,2])
CL Item
Definitely yes (4)
C3842804 (UMLS CUI [1,1])
Item
MEDICAL TREATMENT REQUIRED (ALL PARTICIPANTS)
text
C1514873 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
TREATMNT
Code List
MEDICAL TREATMENT REQUIRED (ALL PARTICIPANTS)
CL Item
Referred to personal physician (1)
C2585021 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
CL Item
Treated in-house (2)
C0087111 (UMLS CUI [1,1])
C3843862 (UMLS CUI [1,2])
CL Item
Hospitalization required (3)
C0019993 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
CL Item
None (4)
C0549184 (UMLS CUI [1,1])
CL Item
Other (5)
C0205394 (UMLS CUI [1,1])
TREATSP
Item
IF OTHER, SPECIFY MEDICAL TREATMENT (ALL PARTICIPANTS)
string
C0087111 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Item
OUTCOME OF AE (ALL PARTICIPANTS)
text
C1705586 (UMLS CUI [1,1])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
OUTCOME
Code List
OUTCOME OF AE (ALL PARTICIPANTS)
CL Item
Resolved (1)
C1709863 (UMLS CUI [1,1])
CL Item
Continuing (2)
C0549178 (UMLS CUI [1,1])
CL Item
Participant lost to follow-up (3)
C1302313 (UMLS CUI [1,1])
CL Item
Chronic (no resolution expected) (4)
C0205191 (UMLS CUI [1,1])
C1517001 (UMLS CUI [2,1])
C1298908 (UMLS CUI [2,2])
C1514893 (UMLS CUI [2,3])
ICD9COD1
Item
PRIMARY ICD9 CODE (ALL PARTICIPANTS)
float
C0205225 (UMLS CUI [1,1])
C2598420 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Item
TYPE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
text
C0877248 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
ADVTYPE
Code List
TYPE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
CL Item
Upset Stomach (01)
C0235309 (UMLS CUI [1,1])
CL Item
Diarrhea (02)
C0011991 (UMLS CUI [1,1])
CL Item
Longer bleeding time (03)
C0040223 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0439590 (UMLS CUI [1,3])
CL Item
Extreme fatigue (04)
C0205403 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
CL Item
Muscle weakness (05)
C0151786 (UMLS CUI [1,1])
CL Item
Thyroid hormone abnormality (06)
C0040135 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
CL Item
Impairment of memory, speech, attention (07)
C0233794 (UMLS CUI [1,1])
C0233715 (UMLS CUI [1,2])
C0238707 (UMLS CUI [1,3])
CL Item
Slowing of mental or physical performance (08)
C0439834 (UMLS CUI [1,1])
C0025353 (UMLS CUI [1,2])
C0439834 (UMLS CUI [2,1])
C0026606 (UMLS CUI [2,2])
CL Item
Change in personality (09)
C0240735 (UMLS CUI [1,1])
CL Item
Intolerance to cold (10)
C0231200 (UMLS CUI [1,1])
C0009264 (UMLS CUI [1,2])
CL Item
Exertional dyspnea (labored breathing) (11)
C0231807 (UMLS CUI [1,1])
CL Item
Hoarseness (12)
C0019825 (UMLS CUI [1,1])
CL Item
Constipation (13)
C0009806 (UMLS CUI [1,1])
CL Item
Decreased sweating (14)
C0205216 (UMLS CUI [1,1])
C0038990 (UMLS CUI [1,2])
CL Item
Easy bruising (15)
C0332219 (UMLS CUI [1,1])
C0009938 (UMLS CUI [1,2])
CL Item
Muscle cramps (16)
C0026821 (UMLS CUI [1,1])
CL Item
Paresthesia (burning or prickling sensation) (17)
C0030554 (UMLS CUI [1,1])
C0439814 (UMLS CUI [1,2])
C0085624 (UMLS CUI [1,3])
CL Item
Dry skin (18)
C0151908 (UMLS CUI [1,1])
CL Item
Kidney stones (19)
C0022650 (UMLS CUI [1,1])
CL Item
Anemia (20)
C0002871 (UMLS CUI [1,1])
CL Item
Nose bleeds (21)
C0014591 (UMLS CUI [1,1])
CL Item
Blood clots (22)
C0302148 (UMLS CUI [1,1])
CL Item
Yellowish or orange complexion (23)
C0424511 (UMLS CUI [1,1])
C0221205 (UMLS CUI [1,2])
CL Item
Elevated serum cholesterol (24)
C0020443 (UMLS CUI [1,1])
CL Item
Difficulty swallowing tablets (25)
C0973461 (UMLS CUI [1,1])
C0566355 (UMLS CUI [1,2])
CL Item
Gas, flatulence, bloating, heartburn (26)
C0946092 (UMLS CUI [1,1])
C0016204 (UMLS CUI [1,2])
C1291077 (UMLS CUI [1,3])
C0018834 (UMLS CUI [1,4])
CL Item
Other gastrointestinal problems (27)
C0017187 (UMLS CUI [1,1])
CL Item
Cardiovascular (28)
C0007222 (UMLS CUI [1,1])
CL Item
Light-headedness, dizziness, headache (29)
C0220870 (UMLS CUI [1,1])
C0012833 (UMLS CUI [1,2])
C0018681 (UMLS CUI [1,3])
CL Item
Allergic response (30)
C1527304 (UMLS CUI [1,1])
CL Item
Urinary problems (31)
C0871563 (UMLS CUI [1,1])
CL Item
Non-allergic oral complications (32)
C0442027 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C1527304 (UMLS CUI [1,4])
CL Item
Malignancy (33)
C0006826 (UMLS CUI [1,1])
CL Item
Other (code=50) (50)
C0205394 (UMLS CUI [1,1])
CL Item
Other (code=51) (51)
C0205394 (UMLS CUI [1,1])
CL Item
Other (code=52) (52)
C0205394 (UMLS CUI [1,1])
CL Item
Other (code=53) (53)
C0205394 (UMLS CUI [1,1])
CL Item
Other (code=55) (55)
C0205394 (UMLS CUI [1,1])
CL Item
Other (code=98) (98)
C0205394 (UMLS CUI [1,1])
CL Item
Other (code=99) (99)
C0205394 (UMLS CUI [1,1])
OBSTIME
Item
YEARS FROM RANDOMIZATION TO DATE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
float
C0439234 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
ADVTIME
Item
DAYS FROM ADVERSE EXPERIENCE OBSERVE DATE TO DATE OF RESOLUTION (ALL PARTICIPANTS)
text
C0439228 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3176356 (UMLS CUI [1,3])
C2985918 (UMLS CUI [1,4])
C0681850 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
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