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The purpose of this study is to compare whether Symbicort Maintenance & Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Symbicort Turbuhaler 160/4.5 µg delivered dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort (Budesonide/Formoterol) | Drug | Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ACQ(5) Score From Baseline at Country Level (China) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Yeoman, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Guangzhou | Guangdong | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26831844 | Derived | Lin J, Tang Y, Xiu Q, Kang J, Cai S, Huang K, Itoh Y, Ling X, Zhong N. Real-life effectiveness of budesonide/formoterol therapy in asthma: A subanalysis of the SMARTASIA study. Allergy Asthma Proc. 2016 Jan-Feb;37(1):27-34. doi: 10.2500/aap.2016.37.3910. | |
| 23557023 | Derived | Zhong N, Lin J, Mehta P, Ngamjanyaporn P, Wu TC, Yunus F. Real-life effectiveness of budesonide/formoterol maintenance and reliever therapy in asthma patients across Asia: SMARTASIA study. BMC Pulm Med. 2013 Apr 4;13:22. doi: 10.1186/1471-2466-13-22. |
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The study consisted of an initial screening visit followed by a 2-week run-in period before a 12-week treatment with investigational drug.
A total of 1022 asthma patients were enrolled at 51 sites in 5 Asian countries: China (21 sites), India (12 sites), Indonesia (3 sites), Thailand (6 sites) and Taiwan (9 sites) during the period July 2009 to August 2010. Of the 1022 enrolled, 862 participants entered into a 12-week treatment with the investigational drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort Turbuhaler | 160/4.5 µg delivered dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline and 12 weeks |
| Change in Overall ACQ(5) Score From Baseline at Country Level (India) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | Baseline and 12 weeks |
| Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | Baseline and 12 weeks |
| Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | Baseline and 12 weeks |
| Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | Baseline and 12 weeks |
| Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline | Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12) | Baseline and 12 weeks |
| Change in AQLQ (S) Domain (Symptom) Scores From Baseline | Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | Baseline and 12 weeks |
| Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline | Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12) | Baseline and 12 weeks |
| Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline | Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12) | Baseline and 12 weeks |
| Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline | Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12) | Baseline and 12 weeks |
| Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period | Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period. | Baseline and 12 weeks |
| Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period | Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period. | Baseline and 12 weeks |
| Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period | Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time | Baseline and 12 weeks |
| Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day | The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day | Baseline and 12 weeks |
| Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day | The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day | Baseline and 12 weeks |
| Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day | The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day | Baseline and 12 weeks |
| Zheng Ahou |
| Henan |
| China |
| Research Site | Wuhan | Hubei | China |
| Research Site | Changsha | Hunan | China |
| Research Site | Qingdao | Shandong | China |
| Research Site | Shanghai | Shanghai Municipality | China |
| Research Site | Beijing | China |
| Research Site | Chengdu | China |
| Research Site | Fuzhou | China |
| Research Site | Hangzhou | China |
| Research Site | Nanjing | China |
| Research Site | Shenyang | China |
| Research Site | Zhengzhou | China |
| Research Site | Hyderabad | Andhra Pradesh | India |
| Research Site | Ahmedabad | Gujarat | India |
| Research Site | Bangalore | Karnataka | India |
| Research Site | Bengaluru | Karnataka | India |
| Research Site | Indore | Madhya Pradesh | India |
| Research Site | Mumbai | Maharashtra | India |
| Research Site | Chennai | Tamil Nadu | India |
| Research Site | Coimbatore | Tamil Nadu | India |
| Research Site | Lucknow | Uttar Pradesh | India |
| Research Site | Noida | Uttar Pradesh | India |
| Research Site | Jakarta | DKI Jakarta | Indonesia |
| Research Site | Surabaya | East Java | Indonesia |
| Research Site | Chiayi City | Taiwan |
| Research Site | Hsinchu | Taiwan |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Taoyuan City | Taiwan |
| Research Site | Bangkok | Bangkok | Thailand |
| Research Site | Pathumwan | Bangkok | Thailand |
| Research Site | Pathum Thani | Changwat Pathum Thani | Thailand |
| Research Site | Nakhonratchasima | Naimuang | Thailand |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Symbicort Turbuhaler | 160/4.5 µg delivered dose |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in ACQ(5) Score From Baseline at Country Level (China) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region. | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in Overall ACQ(5) Score From Baseline at Country Level (India) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region. | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region. | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region. | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand) | Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region. | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline | Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12) | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in AQLQ (S) Domain (Symptom) Scores From Baseline | Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12). | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline | Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12) | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline | Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12) | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline | Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12) | Posted | Aug 2011 | Mean | 95% Confidence Interval | Units on a scale | Baseline and 12 weeks |
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| Secondary | Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period | Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period. | Posted | Aug 2011 | Mean | 95% Confidence Interval | Number of inhalations | Baseline and 12 weeks |
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| Secondary | Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period | Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period. | Posted | Aug 2011 | Mean | 95% Confidence Interval | Number of inhalations | Baseline and 12 weeks |
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| Secondary | Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period | Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time | Posted | Aug 2011 | Mean | Standard Deviation | Number of inhalations | Baseline and 12 weeks |
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| Secondary | Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day | The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day | Posted | Aug 2011 | Mean | Standard Deviation | Percentage of days | Baseline and 12 weeks |
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| Secondary | Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day | The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day | Posted | Aug 2011 | Mean | Standard Deviation | Percentage of days | Baseline and 12 weeks |
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| Secondary | Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day | The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day | Posted | Aug 2011 | Mean | Standard Deviation | Percentage of days | Baseline and 12 weeks |
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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 | Symbicort Turbuhaler | 160/4.5 µg delivered dose | 12 | 862 | 0 | 862 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Nasal Polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Post procedural haemorrhage | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Renal Cysts | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Breast Cancer | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Atrioventricular block complete | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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The design of the study does not allow for any conclusion regarding the effect of Symbicort SMART, it being a within-group comparison
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1625 518062 | 28062 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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