English

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 Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.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 forms  
  1. StudyEvent: SEV1
    1. 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.
    2. 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 Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    3. 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 Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    4. 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 Note: In version 3, the ID has been replaced by ID2 identifier for all subjects.
    5. 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.
    6. 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.
    7. 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.
    8. 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.
    9. 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.
    10. 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.
    11. 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.
    12. 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.
    13. 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.
    14. Subject - Consent Information
    15. Subject - Sample Mapping (including mapping to Coriell IDs)
    16. The data table (n=2 variables) contains information on subjects' annual exposure to sunlight (hours; April through September).
    17. 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.
    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.v2.p1
Description

pht000370.v2.p1

DUMMY ID NUMBER
Description

ID2

Data type

string

IF OTHER, KIDNEY STONES, CARDIOVASCULAR, OR MALIGNANCY, SPECIFY ADVERSE EXPERIENCE DESCRIPTION (ALL PARTICIPANTS)
Description

ADVDESC

Data type

string

ADVERSE EXPERIENCE STATUS (ALL PARTICIPANTS)
Description

ADVSTAT

Data type

text

SEVERITY (ALL PARTICIPANTS)
Description

SEVERITY

Data type

text

RELATIONSHIP TO STUDY DRUG (ALL PARTICIPANTS)
Description

DRUGREL

Data type

text

MEDICAL TREATMENT REQUIRED (ALL PARTICIPANTS)
Description

TREATMNT

Data type

text

IF OTHER, SPECIFY MEDICAL TREATMENT (ALL PARTICIPANTS)
Description

TREATSP

Data type

string

OUTCOME OF AE (ALL PARTICIPANTS)
Description

OUTCOME

Data type

text

PRIMARY ICD9 CODE (ALL PARTICIPANTS)
Description

ICD9COD1

Data type

float

TYPE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
Description

ADVTYPE

Data type

text

YEARS FROM RANDOMIZATION TO DATE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
Description

OBSTIME

Data type

float

DAYS FROM ADVERSE EXPERIENCE OBSERVE DATE TO DATE OF RESOLUTION (ALL PARTICIPANTS)
Description

ADVTIME

Data type

text

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Similar models

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 forms
  1. StudyEvent: SEV1
    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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.
    6. 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.
    7. 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.
    8. 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.
    9. 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.
    10. 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.
    11. 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.
    12. 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.
    13. 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.
    14. Subject - Consent Information
    15. Subject - Sample Mapping (including mapping to Coriell IDs)
    16. The data table (n=2 variables) contains information on subjects' annual exposure to sunlight (hours; April through September).
    17. 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.
    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
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
pht000370.v2.p1
ID2
Item
DUMMY ID NUMBER
string
ADVDESC
Item
IF OTHER, KIDNEY STONES, CARDIOVASCULAR, OR MALIGNANCY, SPECIFY ADVERSE EXPERIENCE DESCRIPTION (ALL PARTICIPANTS)
string
Item
ADVERSE EXPERIENCE STATUS (ALL PARTICIPANTS)
text
ADVSTAT
Code List
ADVERSE EXPERIENCE STATUS (ALL PARTICIPANTS)
CL Item
New (1)
CL Item
Recurrence (2)
CL Item
Increased severity (3)
Item
SEVERITY (ALL PARTICIPANTS)
text
SEVERITY
Code List
SEVERITY (ALL PARTICIPANTS)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life-threatening (4)
Item
RELATIONSHIP TO STUDY DRUG (ALL PARTICIPANTS)
text
DRUGREL
Code List
RELATIONSHIP TO STUDY DRUG (ALL PARTICIPANTS)
CL Item
Probably no (1)
CL Item
Unable to judge (2)
CL Item
Probably yes (3)
CL Item
Definitely yes (4)
Item
MEDICAL TREATMENT REQUIRED (ALL PARTICIPANTS)
text
TREATMNT
Code List
MEDICAL TREATMENT REQUIRED (ALL PARTICIPANTS)
CL Item
Referred to personal physician (1)
CL Item
Treated in-house (2)
CL Item
Hospitalization required (3)
CL Item
None (4)
CL Item
Other (5)
TREATSP
Item
IF OTHER, SPECIFY MEDICAL TREATMENT (ALL PARTICIPANTS)
string
Item
OUTCOME OF AE (ALL PARTICIPANTS)
text
OUTCOME
Code List
OUTCOME OF AE (ALL PARTICIPANTS)
CL Item
Resolved (1)
CL Item
Continuing (2)
CL Item
Participant lost to follow-up (3)
CL Item
Chronic (no resolution expected) (4)
ICD9COD1
Item
PRIMARY ICD9 CODE (ALL PARTICIPANTS)
float
Item
TYPE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
text
ADVTYPE
Code List
TYPE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
CL Item
Upset Stomach (01)
CL Item
Diarrhea (02)
CL Item
Longer bleeding time (03)
CL Item
Extreme fatigue (04)
CL Item
Muscle weakness (05)
CL Item
Thyroid hormone abnormality (06)
CL Item
Impairment of memory, speech, attention (07)
CL Item
Slowing of mental or physical performance (08)
CL Item
Change in personality (09)
CL Item
Intolerance to cold (10)
CL Item
Exertional dyspnea (labored breathing) (11)
CL Item
Hoarseness (12)
CL Item
Constipation (13)
CL Item
Decreased sweating (14)
CL Item
Easy bruising (15)
CL Item
Muscle cramps (16)
CL Item
Paresthesia (burning or prickling sensation) (17)
CL Item
Dry skin (18)
CL Item
Kidney stones (19)
CL Item
Anemia (20)
CL Item
Nose bleeds (21)
CL Item
Blood clots (22)
CL Item
Yellowish or orange complexion (23)
CL Item
Elevated serum cholesterol (24)
CL Item
Difficulty swallowing tablets (25)
CL Item
Gas, flatulence, bloating, heartburn (26)
CL Item
Other gastrointestinal problems (27)
CL Item
Cardiovascular (28)
CL Item
Light-headedness, dizziness, headache (29)
CL Item
Allergic response (30)
CL Item
Urinary problems (31)
CL Item
Non-allergic oral complications (32)
CL Item
Malignancy (33)
CL Item
Other (code=50) (50)
CL Item
Other (code=51) (51)
CL Item
Other (code=52) (52)
CL Item
Other (code=53) (53)
CL Item
Other (code=55) (55)
CL Item
Other (code=98) (98)
CL Item
Other (code=99) (99)
OBSTIME
Item
YEARS FROM RANDOMIZATION TO DATE OF ADVERSE EXPERIENCE (ALL PARTICIPANTS)
float
ADVTIME
Item
DAYS FROM ADVERSE EXPERIENCE OBSERVE DATE TO DATE OF RESOLUTION (ALL PARTICIPANTS)
text
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