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Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017) (EASE)

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ClinicalTrials.gov Identifier: NCT00619359
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : February 12, 2010
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Chemotherapy-Induced Nausea and Vomiting (CINV)
Interventions Drug: Comparator: fosaprepitant dimeglumine
Drug: Comparator: Aprepitant
Drug: Dexamethasone
Drug: Ondansetron
Enrollment 2322
Recruitment Details Patients were recruited from 149 medical centers worldwide. The recruitment period was from 12 Feb 08 through 8 Jun 09.
Pre-assignment Details Cisplatin-naïve patients scheduled to receive cisplatin chemotherapy at a dose of 70 mg/m2 or higher for a documented solid malignancy were screened up to 30 days prior to initiation of chemotherapy. Screening included a complete medical history and physical exam. Informed consent was obtained for patients who agreed to participate in the study.
Arm/Group Title Fosaprepitant Aprepitant
Hide Arm/Group Description Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4. Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
Period Title: Overall Study
Started 1147 1175
Completed 1080 1094
Not Completed 67 81
Reason Not Completed
Adverse Event             32             36
Lost to Follow-up             12             16
Physician Decision             0             7
Protocol Violation             1             1
Withdrawal by Subject             19             20
Progressive Disease             3             1
Arm/Group Title Fosaprepitant Aprepitant Total
Hide Arm/Group Description Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4. Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4. Total of all reporting groups
Overall Number of Baseline Participants 1147 1175 2322
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1147 participants 1175 participants 2322 participants
55.2
(19 to 86)
55.9
(19 to 82)
55.6
(19 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1147 participants 1175 participants 2322 participants
Female
425
  37.1%
427
  36.3%
852
  36.7%
Male
722
  62.9%
748
  63.7%
1470
  63.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1147 participants 1175 participants 2322 participants
American Indian or Alaska Native 32 33 65
Asian 296 306 602
Black or African American 21 22 43
Multi-Racial 149 157 306
Native Hawaiian or Pacific Islander 1 2 3
White 648 655 1303
History of Motion Sickness   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1147 participants 1175 participants 2322 participants
Yes 0 3 3
No 1143 1166 2309
No Data - Assessment Not Completed 4 6 10
[1]
Measure Description: Includes treated patients only.
History of Vomiting with Pregnancy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1147 participants 1175 participants 2322 participants
Yes 3 3 6
No 420 421 841
Female Patients with No Data - No Assessment 2 3 5
Not Applicable - Male Patients 722 748 1470
[1]
Measure Description: Measure is specific to female treated patients only.
1.Primary Outcome
Title A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).
Hide Description The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.
Time Frame Overall (in the 120 hours following initiation of cisplatin chemotherapy).
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment.
Arm/Group Title Fosaprepitant Aprepitant
Hide Arm/Group Description:
Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
Overall Number of Participants Analyzed 1106 1134
Measure Type: Number
Unit of Measure: Participants
795 820
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fosaprepitant, Aprepitant
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.4
Confidence Interval 95%
-4.1 to 3.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).
Hide Description The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.
Time Frame Delayed phase (25 to 120 hours following initiation of cisplatin).
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 1 patient (aprepitant group) had no delayed phase data, and was not included in this analysis.
Arm/Group Title Fosaprepitant Aprepitant
Hide Arm/Group Description:
Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
Overall Number of Participants Analyzed 1106 1133
Measure Type: Number
Unit of Measure: Participants
822 841
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fosaprepitant, Aprepitant
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.1
Confidence Interval 95%
-3.5 to 3.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)
Hide Description The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.
Time Frame Overall (the 120 hours following initiation of cisplatin chemotherapy)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 2 patients (aprepitant group) had no vomiting data, and were excluded from this analysis.
Arm/Group Title Fosaprepitant Aprepitant
Hide Arm/Group Description:
Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
Overall Number of Participants Analyzed 1106 1132
Measure Type: Number
Unit of Measure: Participants
806 844
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fosaprepitant, Aprepitant
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.7
Confidence Interval 95%
-5.3 to 2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.6
Estimation Comments [Not Specified]
Time Frame AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug.
Adverse Event Reporting Description Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.
 
Arm/Group Title Fosaprepitant Aprepitant
Hide Arm/Group Description

Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.

4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.

Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.

6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.

All-Cause Mortality
Fosaprepitant Aprepitant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Fosaprepitant Aprepitant
Affected / at Risk (%) Affected / at Risk (%)
Total   148/1143 (12.95%)   157/1169 (13.43%) 
Blood and lymphatic system disorders     
Anaemia * 1  3/1143 (0.26%)  3/1169 (0.26%) 
Febrile neutropenia * 1  18/1143 (1.57%)  27/1169 (2.31%) 
Leukopenia * 1  4/1143 (0.35%)  2/1169 (0.17%) 
Neutropenia * 1  17/1143 (1.49%)  13/1169 (1.11%) 
Pancytopenia * 1  3/1143 (0.26%)  0/1169 (0.00%) 
Thrombocytopenia * 1  2/1143 (0.17%)  2/1169 (0.17%) 
Cardiac disorders     
Atrial fibrillation * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Cardiac arrest * 1  1/1143 (0.09%)  2/1169 (0.17%) 
Cardio-respiratory arrest * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Cardiopulmonary failure * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Myocardial infarction * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Palpitations * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Supraventricular tachycardia * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Eye disorders     
Conjunctival haemorrhage * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Diplopia * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/1143 (0.09%)  4/1169 (0.34%) 
Abdominal pain upper * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Constipation * 1  2/1143 (0.17%)  1/1169 (0.09%) 
Diarrhoea * 1  3/1143 (0.26%)  8/1169 (0.68%) 
Duodenal ulcer perforation * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Dysphagia * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Enteritis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Faecaloma * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Gastric perforation * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Gastric ulcer haemorrhage * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Gastric ulcer perforation * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Gastritis * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Gastritis erosive * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Gastrointestinal haemorrhage * 1  2/1143 (0.17%)  0/1169 (0.00%) 
Gastrointestinal necrosis * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Haematemesis * 1  1/1143 (0.09%)  1/1169 (0.09%) 
Haematochezia * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Haemorrhoidal haemorrhage * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Intestinal obstruction * 1  0/1143 (0.00%)  2/1169 (0.17%) 
Melaena * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Nausea * 1  4/1143 (0.35%)  3/1169 (0.26%) 
Oesophageal varices haemorrhage * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Regurgitation * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Stomatitis * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Upper gastrointestinal haemorrhage * 1  1/1143 (0.09%)  1/1169 (0.09%) 
Vomiting * 1  13/1143 (1.14%)  7/1169 (0.60%) 
General disorders     
Asthenia * 1  4/1143 (0.35%)  8/1169 (0.68%) 
Chest pain * 1  1/1143 (0.09%)  1/1169 (0.09%) 
Death * 1  2/1143 (0.17%)  5/1169 (0.43%) 
Fatigue * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Mucosal inflammation * 1  3/1143 (0.26%)  2/1169 (0.17%) 
Non-cardiac chest pain * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Pain * 1  1/1143 (0.09%)  2/1169 (0.17%) 
Pyrexia * 1  1/1143 (0.09%)  2/1169 (0.17%) 
Suprapubic pain * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Hepatobiliary disorders     
Acute hepatic failure * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Hepatic failure * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Hyperbilirubinaemia * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Infections and infestations     
Abdominal infection * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Appendicitis * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Bacteraemia * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Cellulitis * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Cystitis * 1  0/1143 (0.00%)  2/1169 (0.17%) 
Diarrhoea infectious * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Gastroenteritis * 1  3/1143 (0.26%)  5/1169 (0.43%) 
Gastroenteritis shigella * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Herpes virus infection * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Herpes zoster * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Incision site abscess * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Lower respiratory tract infection * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Oesophageal candidiasis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Perineal abscess * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Pneumonia * 1  3/1143 (0.26%)  9/1169 (0.77%) 
Postoperative wound infection * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Pyelonephritis * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Respiratory tract infection * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Sepsis * 1  5/1143 (0.44%)  1/1169 (0.09%) 
Septic shock * 1  4/1143 (0.35%)  1/1169 (0.09%) 
Upper respiratory tract infection * 1  1/1143 (0.09%)  1/1169 (0.09%) 
Urinary tract infection * 1  2/1143 (0.17%)  0/1169 (0.00%) 
Wound infection * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Injury, poisoning and procedural complications     
Tracheal obstruction * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Wound dehiscence * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Investigations     
Alanine aminotransferase increased * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Aspartate aminotransferase increased * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Blood creatinine increased * 1  2/1143 (0.17%)  1/1169 (0.09%) 
Blood potassium decreased * 1  0/1143 (0.00%)  2/1169 (0.17%) 
Haemoglobin decreased * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Liver function test abnormal * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Neutrophil count decreased * 1  2/1143 (0.17%)  1/1169 (0.09%) 
Metabolism and nutrition disorders     
Anorexia * 1  3/1143 (0.26%)  5/1169 (0.43%) 
Dehydration * 1  12/1143 (1.05%)  9/1169 (0.77%) 
Diabetes mellitus * 1  2/1143 (0.17%)  0/1169 (0.00%) 
Hyperglycaemia * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Hypokalaemia * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Hyponatraemia * 1  5/1143 (0.44%)  2/1169 (0.17%) 
Malnutrition * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Musculoskeletal and connective tissue disorders     
Flank pain * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant * 1  2/1143 (0.17%)  0/1169 (0.00%) 
Malignant neoplasm progression * 1  2/1143 (0.17%)  2/1169 (0.17%) 
Metastases to central nervous system * 1  2/1143 (0.17%)  0/1169 (0.00%) 
Paraneoplastic syndrome * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Tumour haemorrhage * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Nervous system disorders     
Cerebral ischaemia * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Cerebrovascular accident * 1  1/1143 (0.09%)  2/1169 (0.17%) 
Cognitive disorder * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Convulsion * 1  2/1143 (0.17%)  1/1169 (0.09%) 
Dizziness * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Haemorrhage intracranial * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Ischaemic stroke * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Spinal cord compression * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Psychiatric disorders     
Disorientation * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Psychotic disorder * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Renal and urinary disorders     
Hydronephrosis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Renal failure * 1  3/1143 (0.26%)  2/1169 (0.17%) 
Renal failure acute * 1  3/1143 (0.26%)  1/1169 (0.09%) 
Renal failure chronic * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Renal impairment * 1  2/1143 (0.17%)  0/1169 (0.00%) 
Urinary retention * 1  0/1143 (0.00%)  2/1169 (0.17%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Choking * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Dyspnoea * 1  2/1143 (0.17%)  5/1169 (0.43%) 
Epistaxis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Haemoptysis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Hiccups * 1  1/1143 (0.09%)  1/1169 (0.09%) 
Hydropneumothorax * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Pleural effusion * 1  2/1143 (0.17%)  2/1169 (0.17%) 
Pneumonia aspiration * 1  2/1143 (0.17%)  0/1169 (0.00%) 
Pneumonitis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Pulmonary embolism * 1  1/1143 (0.09%)  1/1169 (0.09%) 
Pulmonary thrombosis * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Respiratory arrest * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Respiratory distress * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Respiratory failure * 1  0/1143 (0.00%)  3/1169 (0.26%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Vascular disorders     
Arterial occlusive disease * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Arterial thrombosis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Arteriosclerosis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Deep vein thrombosis * 1  2/1143 (0.17%)  0/1169 (0.00%) 
Flushing * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Hypertension * 1  0/1143 (0.00%)  1/1169 (0.09%) 
Hypertensive crisis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Hypotension * 1  1/1143 (0.09%)  2/1169 (0.17%) 
Orthostatic hypotension * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Peripheral arterial occlusive disease * 1  0/1143 (0.00%)  3/1169 (0.26%) 
Peripheral embolism * 1  1/1143 (0.09%)  0/1169 (0.00%) 
Thrombosis * 1  1/1143 (0.09%)  0/1169 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Fosaprepitant Aprepitant
Affected / at Risk (%) Affected / at Risk (%)
Total   636/1143 (55.64%)   679/1169 (58.08%) 
Blood and lymphatic system disorders     
Anaemia * 1  17/1143 (1.49%)  7/1169 (0.60%) 
Leukopenia * 1  14/1143 (1.22%)  16/1169 (1.37%) 
Neutropenia * 1  28/1143 (2.45%)  25/1169 (2.14%) 
Thrombocytopenia * 1  17/1143 (1.49%)  14/1169 (1.20%) 
Ear and labyrinth disorders     
Tinnitus * 1  19/1143 (1.66%)  10/1169 (0.86%) 
Gastrointestinal disorders     
Abdominal pain * 1  34/1143 (2.97%)  35/1169 (2.99%) 
Abdominal pain upper * 1  46/1143 (4.02%)  29/1169 (2.48%) 
Constipation * 1  119/1143 (10.41%)  111/1169 (9.50%) 
Diarrhoea * 1  86/1143 (7.52%)  95/1169 (8.13%) 
Dyspepsia * 1  50/1143 (4.37%)  38/1169 (3.25%) 
Gastritis * 1  12/1143 (1.05%)  9/1169 (0.77%) 
Nausea * 1  64/1143 (5.60%)  78/1169 (6.67%) 
Stomatitis * 1  20/1143 (1.75%)  18/1169 (1.54%) 
Vomiting * 1  62/1143 (5.42%)  58/1169 (4.96%) 
General disorders     
Asthenia * 1  94/1143 (8.22%)  129/1169 (11.04%) 
Chest pain * 1  15/1143 (1.31%)  18/1169 (1.54%) 
Fatigue * 1  53/1143 (4.64%)  56/1169 (4.79%) 
Infusion site pain * 1  16/1143 (1.40%)  1/1169 (0.09%) 
Mucosal inflammation * 1  22/1143 (1.92%)  32/1169 (2.74%) 
Pain * 1  11/1143 (0.96%)  10/1169 (0.86%) 
Pyrexia * 1  22/1143 (1.92%)  23/1169 (1.97%) 
Injury, poisoning and procedural complications     
Accidental overdose * 1  11/1143 (0.96%)  13/1169 (1.11%) 
Investigations     
Alanine aminotransferase increased * 1  15/1143 (1.31%)  17/1169 (1.45%) 
Blood creatinine increased * 1  14/1143 (1.22%)  12/1169 (1.03%) 
Metabolism and nutrition disorders     
Anorexia * 1  74/1143 (6.47%)  101/1169 (8.64%) 
Dehydration * 1  20/1143 (1.75%)  32/1169 (2.74%) 
Hypokalaemia * 1  13/1143 (1.14%)  10/1169 (0.86%) 
Hyponatraemia * 1  10/1143 (0.87%)  13/1169 (1.11%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  16/1143 (1.40%)  17/1169 (1.45%) 
Pain in extremity * 1  18/1143 (1.57%)  16/1169 (1.37%) 
Nervous system disorders     
Dizziness * 1  38/1143 (3.32%)  34/1169 (2.91%) 
Dysgeusia * 1  14/1143 (1.22%)  14/1169 (1.20%) 
Headache * 1  46/1143 (4.02%)  48/1169 (4.11%) 
Psychiatric disorders     
Insomnia * 1  14/1143 (1.22%)  19/1169 (1.63%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  26/1143 (2.27%)  22/1169 (1.88%) 
Dyspnoea * 1  16/1143 (1.40%)  15/1169 (1.28%) 
Hiccups * 1  63/1143 (5.51%)  74/1169 (6.33%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  12/1143 (1.05%)  16/1169 (1.37%) 
Erythema * 1  13/1143 (1.14%)  4/1169 (0.34%) 
Vascular disorders     
Hypertension * 1  17/1143 (1.49%)  6/1169 (0.51%) 
Hypotension * 1  11/1143 (0.96%)  12/1169 (1.03%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00619359    
Other Study ID Numbers: 0517-017
MK0517-017
2007_594
First Submitted: January 28, 2008
First Posted: February 21, 2008
Results First Submitted: January 19, 2010
Results First Posted: February 12, 2010
Last Update Posted: March 21, 2017