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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0869-184 | Other Identifier | protocol number |
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This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korean Participants Treated With EMEND (aprepitant) | Participants receiving EMEND on Treatment Days 1, 2, and 3 concomitantly with a corticosteroid and a 5-hydroxytryptamine 3 (5-HT3) antagonist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMEND | Drug | EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect). | Up to 14 days following the cessation of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Korean patients treated with EMEND in usual practice.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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South Korean hospitals provided 3,546 participant's case report forms, 9/18/2006-1/22/2012. 407 participants were excluded: 201 violated dosage/administration, 173 lost to follow-up, 15 duplicated participants, 10 assessed before the contracted date, 3 previously received EMEND, 3 violated inclusion/exclusion criteria, and 2 didn't receive EMEND.
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| ID | Title | Description |
|---|---|---|
| FG000 | Korean Participants Treated With EMEND (Aprepitant) | EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Korean Participants Treated With EMEND (Aprepitant) | EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy | The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect). | The Efficacy Evaluable Population consisted of participants treated with EMEND for 3 days and assessed by an investigator for efficacy. Participants were excluded from efficacy analysis for having a EMEND administration period less than 3 days (143 participants) or unavailability of final efficacy evaluation (1 participant). | Posted | Number | participants | Up to 14 days following the cessation of treatment |
|
Up to 14 days following the cessation of treatment
Participants who completed more than one follow up visit were included in the cases for safety evaluation.
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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 | Participants in the Safety Analysis | Participants included in the Safety Analysis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009325 | Nausea |
| 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 |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Description |
|---|
| OG000 | Participants Treated With EMEND |
|
|
| 89 |
| 3,139 |
| 399 |
| 3,139 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Brain oedema | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Nephropathy toxic | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
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| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Tumour compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Infarction | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Embolism | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Brain herniation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Gastritis atrophic | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypophagia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
If an investigator intends to publish trial results in an academic journal, prior consent of the sponsor must be obtained.