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| Name | Class |
|---|---|
| Concentrics Research | OTHER |
| Idea Evolver | INDUSTRY |
| The Cleveland Clinic | OTHER |
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The purpose of this AUS is to evaluate the extent to which participants can safely and effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to the label.
This is a single-arm, interventional, phase III Self-Selection (SS) and Actual Use Study (AUS) using a technology assisted tool within a Web App. The open-label study will enroll approximately 1220 participants who qualify for treatment based on the data they enter into the Web App of which an estimated 1000 participants will ultimately proceed to the use phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label, Single Arm Technology-Assisted Cholesterol Trial | Other | Open Label Single Arm study in All-comers population who self-report having concern about high cholesterol or heart health |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 mg rosuvastatin calcium with a Web App (combination product) | Combination Product | The combination product will be a Drug (Rosuvastatin calcium 5 mg) and Software as a Medical Device (Web App that features a Technology-Assisted Self-Selection (TASS) tool). Rosuvastatin calcium 5 mg will be taken orally, 1 tablet daily to use for lowering cholesterol, a key risk factor that can lead to heart disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population) | Proportion of participants that had a correct tass outcome at their initial TASS assessment | Study day -30 to -1, at initial TASS assessment |
| Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population) | Proportion of participants that had a correct tass outcome at their final TASS assessment | From enrollment to end of the home use period at 180 days, at final TASS Assessment |
| Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population) | From enrollment to end of the home use period at 180 days, at final assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population) | From enrollment to end of the home use period at 180 days | |
| Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population) |
Not provided
Inclusion Criteria:
Additional Criteria for Inclusion for Actual Use (at Virtual Visit 1)
1. Participant reads and signs the Informed Consent form
Exclusion Criteria:
The participant or anyone in their household is currently employed by any of the following:
The participant has ever been trained or employed as a healthcare professional (physician, nurse, nurse practitioner, physician assistant, pharmacist).
The participant has, or cannot recall whether he/she has, received an investigational therapy as part of a clinical trial in the previous twelve (12) months
The participant is not willing to provide contact information.
Previous enrollment in the present study.
The participant has a mailing address in Alaska or their mailing address is a Post Office (PO) Box.
The participant is not willing to complete an eDiary
The participant is a woman of childbearing potential and is not following contraception guidelines or is not willing to follow contraception guidelines including practicing abstinence or using at least 1 of the following acceptable methods of birth control for at least 1 month prior to entry into the study and for 1 month after study completion: hormonal -oral, implantable, injectable, or transdermal; mechanical - spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device; or surgical sterilization of partner.
The participant does not have access to the internet.
The participant does not have an email address or the ability to receive emails.
The participant responds to the Single Item Literacy Screener 2 (SILS2) question (See References) with either 'extremely' or 'quite a bit.' (If the quota for normal literacy is met, but the limited literacy target is not met, the SILS2 exclusion will be used to help increase the percentage of limited literacy participants at Virtual Visit 1. Participants identified as normal literacy by Rapid Estimate of Adult Literacy in Medicine [REALM] testing at Virtual Visit 1 will not be excluded from entry into the treatment phase of the study.)
Inability to conduct interviews in a private location so that sensitive information about the participant or study would not be overheard by others not permitted to hear such information.
Additional Criteria for Exclusion from Actual Use (at Virtual Visit 1)
Confirmation by Concentrics Central Medical Operations Group (CMOG) clinician:
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| Name | Affiliation | Role |
|---|---|---|
| William C. Miller, M.D. | Concentrics Central Medical Operations Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Indianapolis | Indiana | 46240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18335281 | Background | Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, Vanryn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008 May;23(5):561-6. doi: 10.1007/s11606-008-0520-5. Epub 2008 Mar 12. | |
| 8349060 | Background |
| Label | URL |
|---|---|
| redacted CSP | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nonprescription Rosuvastatin | Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonprescription Rosuvastatin | Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The full analysis set population |
| 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 | Overall Correct Initial TASS Outcome, Worst Case Imputation, First Co-Primary Endpoint (Self-Selection Population) | Proportion of participants that had a correct tass outcome at their initial TASS assessment | Posted | Count of Participants | Participants | Study day -30 to -1, at initial TASS assessment |
|
|
treatment period (6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nonprescription Rosuvastatin | Combination Product: 5 mg rosuvastatin calcium with a Web App (combination product) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
TACTiC was conducted during the COVID-19 pandemic. However, the pandemic was not judged to adversely impact the quality of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2022 | Oct 9, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2023 | Aug 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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This is a 6-month, single-arm, uncontrolled technology-assisted Self-Selection and Actual Use Study to evaluate the use of nonprescription rosuvastatin 5 mg in combination with a Web App. It is an open-label study where participants qualify for treatment based on the medical history, laboratory and blood pressure data they enter into the Web App, accessed on their own device on the internet.
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|
|
Participants who Self-Identify a Stop Use Warning also identified by the CMOG, and Stop Medication. |
| From enrollment to end of the home use period at 180 days |
| Participants Who Self-Identify a Do Not Use Warning Also Identified by the CMOG at Final Use Assessment(Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit) | From enrollment to end of the home use period at 180 days |
| Participants Who Self-Identify an Ask a Doctor Before Use Warning Also Identified by the CMOG at Final Use Assessment (Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit) | From enrollment to end of the home use period at 180 days |
| Participants With Overall Compliance Between 50% and 120% | Overall compliance is defined as 100 * (total number of pills taken) / (Intended duration of treatment in days) | From enrollment to end of the home use period at 180 days |
| Participants Who Were Longitudinally Compliant (Per Protocol Population) | An individual is longitudinally compliant if they have 50% to 120% compliance across each supply period. | From enrollment to end of the home use period at 180 days |
| Participants Who Were Persistent (Per Protocol Population) | An individual is persistent if they ordered the full 180 days of treatment and were eligible for continuous treatment | From enrollment to end of the home use period at 180 days |
| Davis TC, Long SW, Jackson RH, Mayeaux EJ, George RB, Murphy PW, Crouch MA. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med. 1993 Jun;25(6):391-5. |
| 30586774 | Background | Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10. |
| 38599257 | Derived | Nissen SE, Hutchinson HG, Wolski K, Watson K, Martin SS, Michos ED, Weintraub WS, Morris M, Cho L, Laffin L, Jacoby D, Ballantyne CM, Ekelund J, Birve F, Menon V, Strzelecki M, Ridker PM. A Technology-Assisted Web Application for Consumer Access to a Nonprescription Statin Medication. J Am Coll Cardiol. 2024 May 28;83(21):2080-2088. doi: 10.1016/j.jacc.2024.03.388. Epub 2024 Apr 8. |
| redacted SAP | View source |
| redacted CSR Synopsis | View source |
| Withdrawal by Subject |
|
| Death |
|
| Mean |
| Standard Deviation |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | The full analysis set population | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The full analysis set population | Number | Participants |
|
|
|
| Primary | Overall Correct Final Use Outcome With Mitigation, Second Co-primary Endpoint (Per Protocol Population) | Proportion of participants that had a correct tass outcome at their final TASS assessment | Posted | Count of Participants | Participants | From enrollment to end of the home use period at 180 days, at final TASS Assessment |
|
|
|
|
| Primary | Percent Change From Baseline in Verified LDL-C Regardless of Final Use Outcome (AUS ITT Population) | Posted | Mean | 95% Confidence Interval | Percent change of baseline | From enrollment to end of the home use period at 180 days, at final assessment |
|
|
|
|
| Secondary | Participants Eligble for Continuous Treatment Who Self-Tested With a Verified LDL-C Retest During Study, Overall and by Subgroups (Per Protocol Population) | Participants in the per protocol analysis set eligble for continuous treatment | Posted | Count of Participants | Participants | From enrollment to end of the home use period at 180 days |
|
|
|
| Secondary | Participants Who Self-Identify a Stop Use Warning Also Identified by the CMOG, and Stop Medication (Per Protocol Population) | Participants who Self-Identify a Stop Use Warning also identified by the CMOG, and Stop Medication. | Participants who had a stop use warning identified by the CMOG at final use assessment | Posted | Count of Participants | Participants | From enrollment to end of the home use period at 180 days |
|
|
|
| Secondary | Participants Who Self-Identify a Do Not Use Warning Also Identified by the CMOG at Final Use Assessment(Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit) | Participants in the per protocol population who had a do not use warning identified by the CMOG at final use visit | Posted | Count of Participants | Participants | From enrollment to end of the home use period at 180 days |
|
|
|
| Secondary | Participants Who Self-Identify an Ask a Doctor Before Use Warning Also Identified by the CMOG at Final Use Assessment (Per Protocol Population, Participants Who Had a do Not Use Warning Identified by the CMOG at Final Use Visit) | Participants in the per protocol population who had an ask a doctor before use warning identified by the CMOG at final use visit | Posted | Count of Participants | Participants | From enrollment to end of the home use period at 180 days |
|
|
|
| Secondary | Participants With Overall Compliance Between 50% and 120% | Overall compliance is defined as 100 * (total number of pills taken) / (Intended duration of treatment in days) | Participants in the per protocol population whose overall compliance was assessed | Posted | Count of Participants | Participants | From enrollment to end of the home use period at 180 days |
|
|
|
| Secondary | Participants Who Were Longitudinally Compliant (Per Protocol Population) | An individual is longitudinally compliant if they have 50% to 120% compliance across each supply period. | Participants in the per protocol population for whom supply period compliance was assessed across all supply periods | Posted | Count of Participants | Participants | From enrollment to end of the home use period at 180 days |
|
|
|
| Secondary | Participants Who Were Persistent (Per Protocol Population) | An individual is persistent if they ordered the full 180 days of treatment and were eligible for continuous treatment | Participants in the per protocol population that were eligible for continuous treatment | Posted | Count of Participants | Participants | From enrollment to end of the home use period at 180 days |
|
|
|
| 1 |
| 1,177 |
| 27 |
| 1,177 |
| 493 |
| 1,177 |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Chromophobe renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Schizoaffective disorder | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertensive urgency | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Suspected covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Sars-cov-2 test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertensive urgency | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
The results of this study may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
| D009750 |
| Nutritional and Metabolic Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |