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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0869-225 | Other Identifier | Merck protocol number |
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This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors. MECs include a number of commonly used cancer chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based regimens.
The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant Regimen | Experimental | Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3. |
|
| Control Regimen | Active Comparator | Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant | Drug | Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With No Vomiting - Overall Stage | A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC). | Hour 0 on Day 1 to Day 5 (approximately 120 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. | Hour 0 on Day 1 to Day 5 (approximately 120 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27826874 | Result | Kim JE, Jang JS, Kim JW, Sung YL, Cho CH, Lee MA, Kim DJ, Ahn MJ, Lee KY, Sym SJ, Lim MC, Jung H, Cho EK, Min KW. Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. Support Care Cancer. 2017 Mar;25(3):801-809. doi: 10.1007/s00520-016-3463-0. Epub 2016 Nov 8. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant Regimen | Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Aprepitant Placebo | Drug | Aprepitant Placebo (PO, QD) on Days 1, 2, and 3 |
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| Ondansetron | Drug | Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3 |
|
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| Dexamethasone | Drug | Dexamethasone (20 mg or 12 mg, PO) on Day 1 |
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| Ondansetron Placebo | Drug | Ondansetron Placebo (PO, BID) on Days 2 and 3 |
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| Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride). | Drug | Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride). |
|
| Number of Emetic Events - Overall Stage | The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented. | Hour 0 on Day 1 to Day 5 (approximately 120 hours) |
| Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage | Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: "How much nausea have you had over the last 24 hours?" The left end of the scale (0 mm) was labeled "no nausea," and the right end of the scale (100 mm) is labeled "nausea as bad as it could be." In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm. | Days 1 to Day 5 |
| Percentage of Participants With No Impact on Daily Life - Overall Stage | The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, "No Impact" on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC. | Day 6 |
| Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages | The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. | Day 1 to Day 5 |
| Percentage of Participants With One or More Clinical Adverse Event | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event. | Day 1 through Day 29 (Up to 28 days after first dose of study drug) |
| Percentage of Participants With No Vomiting - Acute and Delayed Stages | A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. | Day 1, Day 2 to Day 5 |
| FG001 |
| Control Regimen |
Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The Baseline Analysis Population consists of All Treated Participants. Two participants in each treatment group did not receive study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant Regimen | Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3. |
| BG001 | Control Regimen | Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| 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 | The Percentage of Participants With No Vomiting - Overall Stage | A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC). | The modified intention-to-treat (mITT) population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Posted | Number | Percentage of Participants | Hour 0 on Day 1 to Day 5 (approximately 120 hours) |
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| Secondary | Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages | A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Posted | Number | Percentage of Participants | Hour 0 on Day 1 to Day 5 (approximately 120 hours) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Emetic Events - Overall Stage | The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented. | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Posted | Number | Number of Emetic Events | Hour 0 on Day 1 to Day 5 (approximately 120 hours) |
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| Secondary | Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage | Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: "How much nausea have you had over the last 24 hours?" The left end of the scale (0 mm) was labeled "no nausea," and the right end of the scale (100 mm) is labeled "nausea as bad as it could be." In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm. | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Posted | Number | Percentage of Participants | Days 1 to Day 5 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With No Impact on Daily Life - Overall Stage | The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, "No Impact" on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC. | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug, had ≥1 post-treatment assessment on Day 1 and Day 2 and completed the FLIE questionnaire on Day 6. | Posted | Number | Percentage of Participants | Day 6 |
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| Secondary | Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages | The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Posted | Number | Percentage of Participants | Day 1 to Day 5 |
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| Secondary | Percentage of Participants With One or More Clinical Adverse Event | An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event. | All randomized participants who received chemotherapy and took ≥1 dose of study drug. | Posted | Number | Percentage of Participants | Day 1 through Day 29 (Up to 28 days after first dose of study drug) |
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| Secondary | Percentage of Participants With No Vomiting - Acute and Delayed Stages | A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. | The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2. | Posted | Number | Percentage of Participants | Day 1, Day 2 to Day 5 |
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Up to 28 days after first dose of study drug (Up to 29 days)
The safety population consisted of all randomized participants who received chemotherapy and took ≥1 dose of study drug. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event.
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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 | Aprepitant Regimen | Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3. | 25 | 242 | 87 | 242 | ||
| EG001 | Control Regimen | Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3. | 16 | 248 | 96 | 248 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Enterovesical fistula | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Wound dihiscence | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| C004180 | dexamethasone 21-phosphate |
| C018038 | dexamethasone acetate |
| D002123 | Calcium Dobesilate |
| D017829 | Granisetron |
| C060344 | dolasetron |
| D000077526 | Tropisetron |
| D008787 | Metoclopramide |
| C033968 | alizapride |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 40 to 49 years |
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| 50 to 59 years |
|
| 60 to 69 years |
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| ≥70 years |
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| Male |
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| Units |
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| Participants |
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| Participants |
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