Trial Outcomes & Findings for Re-examination Study of EMEND (Aprepitant) (MK-0869-184) (NCT NCT01074255)

Last Updated: 2015-04-21

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

3546 participants

Primary outcome timeframe

Up to 14 days following the cessation of treatment

Results posted on

2015-04-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	3141
Overall Study Treated	3139
Overall Study COMPLETED	3139
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Did not receive EMEND	2

Baseline Characteristics

Re-examination Study of EMEND (Aprepitant) (MK-0869-184)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Korean Participants Treated With EMEND (Aprepitant) n=3139 Participants 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.
Age, Customized <40 years	296 Participants n=5 Participants
Age, Customized 40 to 49 years	635 Participants n=5 Participants
Age, Customized 50 to 59 years	898 Participants n=5 Participants
Age, Customized 60 to 69 years	957 Participants n=5 Participants
Age, Customized ≥70 years	353 Participants n=5 Participants
Sex/Gender, Customized Male	1729 Participants n=5 Participants
Sex/Gender, Customized Female	1410 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days following the cessation of treatment

Population: 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).

Outcome measures

Outcome measures
Measure	Participants Treated With EMEND n=2995 Participants
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy Excellent	438 participants
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy Good	2056 participants
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy Fair	446 participants
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy Poor	52 participants
Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy None	3 participants

Adverse Events

Participants in the Safety Analysis

Serious events: 89 serious events

Other events: 399 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants in the Safety Analysis n=3139 participants at risk Participants included in the Safety Analysis
Gastrointestinal disorders Nausea	0.19% 6/3139 • Number of events 6 • 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.
Gastrointestinal disorders Diarrhoea	0.16% 5/3139 • Number of events 5 • 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.
Gastrointestinal disorders Vomiting	0.10% 3/3139 • Number of events 3 • 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.
Gastrointestinal disorders Abdominal pain upper	0.03% 1/3139 • Number of events 1 • 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.
General disorders Asthenia	0.54% 17/3139 • Number of events 17 • 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.
General disorders Mucosal inflammation	0.06% 2/3139 • Number of events 2 • 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.
Metabolism and nutrition disorders Decreased appetite	0.13% 4/3139 • Number of events 4 • 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.
Metabolism and nutrition disorders Metabolic acidosis	0.03% 1/3139 • Number of events 1 • 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.
Blood and lymphatic system disorders Neutropenia	0.70% 22/3139 • Number of events 22 • 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.
Blood and lymphatic system disorders Thrombocytopenia	0.03% 1/3139 • Number of events 1 • 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.
Blood and lymphatic system disorders Febrile neutropenia	0.45% 14/3139 • Number of events 14 • 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.
Blood and lymphatic system disorders Pancytopenia	0.06% 2/3139 • Number of events 2 • 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.
Nervous system disorders Cerebral infarction	0.03% 1/3139 • Number of events 1 • 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.
Nervous system disorders Brain oedema	0.03% 1/3139 • Number of events 1 • 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.
Nervous system disorders Depressed level of consciousness	0.06% 2/3139 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.06% 2/3139 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.06% 2/3139 • Number of events 2 • 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.
Investigations White blood cell count decreased	0.10% 3/3139 • Number of events 3 • 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.
Investigations Platelet count decreased	0.06% 2/3139 • Number of events 2 • 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.
Infections and infestations Pneumonia	0.22% 7/3139 • Number of events 7 • 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.
Infections and infestations Oral candidiasis	0.06% 2/3139 • Number of events 2 • 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.
Infections and infestations Sepsis	0.10% 3/3139 • Number of events 3 • 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.
Infections and infestations Septic shock	0.13% 4/3139 • Number of events 4 • 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.
Renal and urinary disorders Nephropathy toxic	0.03% 1/3139 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.13% 4/3139 • Number of events 4 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour compression	0.03% 1/3139 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.03% 1/3139 • Number of events 1 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.03% 1/3139 • Number of events 1 • 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.
Vascular disorders Infarction	0.03% 1/3139 • Number of events 1 • 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.
Vascular disorders Embolism	0.03% 1/3139 • Number of events 1 • 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.
Injury, poisoning and procedural complications Brain herniation	0.03% 1/3139 • Number of events 1 • 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.
Cardiac disorders Cardiac failure acute	0.03% 1/3139 • Number of events 1 • 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.
Gastrointestinal disorders Dyspepsia	0.03% 1/3139 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal pain	0.16% 5/3139 • Number of events 5 • 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.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.06% 2/3139 • Number of events 2 • 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.
Gastrointestinal disorders Ileus	0.03% 1/3139 • Number of events 1 • 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.
Gastrointestinal disorders Melaena	0.03% 1/3139 • Number of events 1 • 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.
Gastrointestinal disorders Gastritis atrophic	0.03% 1/3139 • Number of events 1 • 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.
General disorders Pyrexia	0.13% 4/3139 • Number of events 4 • 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.
General disorders Multi-organ failure	0.03% 1/3139 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypophagia	0.13% 4/3139 • Number of events 4 • 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.
Metabolism and nutrition disorders Hyperglycaemia	0.03% 1/3139 • Number of events 1 • 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.
Nervous system disorders Convulsion	0.03% 1/3139 • Number of events 1 • 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.
Nervous system disorders Syncope	0.03% 1/3139 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.03% 1/3139 • Number of events 1 • 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.
Investigations Neutrophil count decreased	0.10% 3/3139 • Number of events 3 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.03% 1/3139 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.03% 1/3139 • Number of events 1 • 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.
Infections and infestations Herpes zoster	0.03% 1/3139 • Number of events 1 • 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.
Cardiac disorders Acute myocardial infarction	0.03% 1/3139 • Number of events 1 • 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.
Cardiac disorders Cardiac arrest	0.03% 1/3139 • Number of events 1 • 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.
Hepatobiliary disorders Hepatitis	0.03% 1/3139 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Participants in the Safety Analysis n=3139 participants at risk Participants included in the Safety Analysis
Gastrointestinal disorders Nausea	9.0% 281/3139 • Number of events 285 • 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.
Metabolism and nutrition disorders Decreased Appetite	6.2% 195/3139 • Number of events 195 • 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.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator intends to publish trial results in an academic journal, prior consent of the sponsor must be obtained.
Publication restrictions are in place

Restriction type: OTHER