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Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)

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ClinicalTrials.gov Identifier: NCT02142738
Recruitment Status : Active, not recruiting
First Posted : May 20, 2014
Results First Posted : July 7, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Carcinoma
Interventions Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Drug: Pemetrexed
Drug: Cisplatin
Drug: Gemcitabine
Enrollment 305
Recruitment Details  
Pre-assignment Details

Per protocol, it was planned that participants would be randomized 1:1 to receive either pembrolizumab or investigator-choice standard of care (SOC) chemotherapy and data analysis would be conducted on the two treatment arms: Pembrolizumab and SOC Chemotherapy.

As of the 09 May 2016 data cutoff date, 189 participants were ongoing in the study.

Arm/Group Title Pembrolizumab SOC Chemotherapy
Hide Arm/Group Description Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation. Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
Period Title: Overall Study
Started 154 151
Treated 154 150
Completed 0 0
Not Completed 154 151
Reason Not Completed
Adverse Event             9             8
Death             33             55
Progressive Disease             0             1
Withdrawal by Subject             5             5
Ongoing in Study             107             82
Arm/Group Title Pembrolizumab SOC Chemotherapy Total
Hide Arm/Group Description Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation. Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation. Total of all reporting groups
Overall Number of Baseline Participants 154 151 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 151 participants 305 participants
63.9  (10.1) 64.6  (9.5) 64.2  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 151 participants 305 participants
Female
62
  40.3%
56
  37.1%
118
  38.7%
Male
92
  59.7%
95
  62.9%
187
  61.3%
1.Primary Outcome
Title Progression Free Survival (PFS) Rate at Month 6
Hide Description PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists’ (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The PFS rate at Month 6 was calculated.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.
Arm/Group Title Pembrolizumab SOC Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
Overall Number of Participants Analyzed 154 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
62.1
(53.8 to 69.4)
50.3
(41.9 to 58.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, SOC Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments One-sided p-value based on log-rank test
Method Regression, Cox
Comments Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.37 to 0.68
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS) Rate at Month 6
Hide Description OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. In those instances where participants were confirmed to be alive on the visit cut-off date of 09 May 2016, survival was censored as of 09 May 2016. The OS rate at Month 6 was calculated.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.
Arm/Group Title Pembrolizumab SOC Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
Overall Number of Participants Analyzed 154 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
80.2
(72.9 to 85.7)
72.4
(64.5 to 78.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, SOC Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments One-sided p-value based on log-rank test
Method Regression, Cox
Comments Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.41 to 0.89
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The ORR through the data cutoff date of 09 May 2016 is presented for each treatment group.
Time Frame Through data cutoff data of 09 May 2016 (Up to approximately 1.6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.
Arm/Group Title Pembrolizumab SOC Chemotherapy
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
Overall Number of Participants Analyzed 154 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
44.8
(36.8 to 53.0)
27.8
(20.8 to 35.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab, SOC Chemotherapy
Comments H0: difference in %=0 vs. H1: difference in % >0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments One-sided p-value for testing
Method Miettinen & Nurminem method
Comments Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 16.6
Confidence Interval (2-Sided) 95%
6.0 to 27.0
Estimation Comments [Not Specified]
Time Frame Serious adverse events (AEs): Up to 90 days after last dose of study treatment (up to approximately 1.8 years) Other (non-serious) AEs: Up to 30 days after last dose of study treatment (up to approximately 1.6 years)
Adverse Event Reporting Description The safety population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.
 
Arm/Group Title Pembrolizumab SOC Chemotherapy
Hide Arm/Group Description Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation. Participants received SOC platinum-based chemotherapy, administered as IV infusion. If PD occurred, participants may have been able to receive pembrolizumab on Day 1 of each 21-day cycle for the remainder of the study or until documented PD or participant discontinuation.
All-Cause Mortality
Pembrolizumab SOC Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pembrolizumab SOC Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/154 (44.16%)      66/150 (44.00%)    
Blood and lymphatic system disorders     
Anaemia  1  2/154 (1.30%)  3 5/150 (3.33%)  6
Febrile neutropenia  1  0/154 (0.00%)  0 3/150 (2.00%)  3
Leukocytosis  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Pancytopenia  1  0/154 (0.00%)  0 3/150 (2.00%)  3
Thrombocytopenia  1  0/154 (0.00%)  0 3/150 (2.00%)  3
Cardiac disorders     
Angina pectoris  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Atrial fibrillation  1  0/154 (0.00%)  0 2/150 (1.33%)  2
Bradycardia  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Cardiac arrest  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Cardiac failure  1  1/154 (0.65%)  1 2/150 (1.33%)  2
Cardio-respiratory arrest  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Coronary artery disease  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Ischaemic cardiomyopathy  1  0/154 (0.00%)  0 1/150 (0.67%)  2
Pericardial effusion  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Pericarditis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Right ventricular failure  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Supraventricular tachycardia  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Endocrine disorders     
Hyperthyroidism  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Hypophysitis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Colitis  1  2/154 (1.30%)  2 0/150 (0.00%)  0
Constipation  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Diarrhoea  1  3/154 (1.95%)  4 1/150 (0.67%)  1
Enterocolitis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Faecaloma  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Gastric ulcer  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Gastritis erosive  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Nausea  1  0/154 (0.00%)  0 2/150 (1.33%)  2
Pancreatitis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Small intestinal obstruction  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Stomatitis  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Vomiting  1  1/154 (0.65%)  1 0/150 (0.00%)  0
General disorders     
Chest pain  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Death  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Face oedema  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Fatigue  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Gait disturbance  1  0/154 (0.00%)  0 1/150 (0.67%)  1
General physical health deterioration  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Multiple organ dysfunction syndrome  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Oedema peripheral  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Pyrexia  1  2/154 (1.30%)  2 1/150 (0.67%)  1
Sudden death  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Hepatobiliary disorders     
Acute hepatic failure  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Immune system disorders     
Anaphylactic shock  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Hypersensitivity  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Bronchitis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Cellulitis  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Clostridium difficile colitis  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Device related infection  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Gastroenteritis viral  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Infectious pleural effusion  1  1/154 (0.65%)  2 0/150 (0.00%)  0
Infective exacerbation of chronic obstructive airways disease  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Lower respiratory tract infection  1  2/154 (1.30%)  2 2/150 (1.33%)  2
Lung infection  1  2/154 (1.30%)  2 2/150 (1.33%)  2
Neutropenic sepsis  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Oral candidiasis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Peritonsillar abscess  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Pneumonia  1  3/154 (1.95%)  4 9/150 (6.00%)  9
Pneumonia streptococcal  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Pulmonary sepsis  1  0/154 (0.00%)  0 2/150 (1.33%)  2
Respiratory tract infection  1  0/154 (0.00%)  0 2/150 (1.33%)  2
Sepsis  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Septic shock  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Skin infection  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Splenic abscess  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Urinary tract infection  1  1/154 (0.65%)  1 2/150 (1.33%)  2
Urosepsis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Injury, poisoning and procedural complications     
Infusion related reaction  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Pulmonary radiation injury  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Radiation oesophagitis  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Rib fracture  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Toxicity to various agents  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Investigations     
Alanine aminotransferase increased  1  2/154 (1.30%)  2 0/150 (0.00%)  0
Aspartate aminotransferase increased  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Bilirubin conjugated increased  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Hepatic enzyme increased  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Platelet count decreased  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Transaminases increased  1  1/154 (0.65%)  2 0/150 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Dehydration  1  1/154 (0.65%)  2 0/150 (0.00%)  0
Diabetes mellitus  1  2/154 (1.30%)  2 0/150 (0.00%)  0
Diabetic ketoacidosis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Hypercalcaemia  1  0/154 (0.00%)  0 3/150 (2.00%)  3
Hyperglycaemia  1  3/154 (1.95%)  3 0/150 (0.00%)  0
Hypocalcaemia  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Hyponatraemia  1  4/154 (2.60%)  5 0/150 (0.00%)  0
Hypovolaemia  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Back pain  1  1/154 (0.65%)  1 3/150 (2.00%)  3
Muscle haemorrhage  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Musculoskeletal pain  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Osteolysis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Spinal pain  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder neoplasm  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Cancer pain  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Gastrointestinal carcinoma  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Infected neoplasm  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Malignant neoplasm progression  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Metastases to meninges  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Cerebrovascular accident  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Haemorrhagic stroke  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Ischaemic stroke  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Transient ischaemic attack  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Product Issues     
Device dislocation  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Psychiatric disorders     
Insomnia  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Restlessness  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/154 (0.00%)  0 3/150 (2.00%)  3
Hypertensive nephropathy  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Tubulointerstitial nephritis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Reproductive system and breast disorders     
Ovarian haemorrhage  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Atelectasis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Bronchial obstruction  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Chronic obstructive pulmonary disease  1  4/154 (2.60%)  5 1/150 (0.67%)  2
Epistaxis  1  0/154 (0.00%)  0 2/150 (1.33%)  2
Haemoptysis  1  2/154 (1.30%)  2 0/150 (0.00%)  0
Organising pneumonia  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Painful respiration  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Pleural effusion  1  5/154 (3.25%)  5 3/150 (2.00%)  3
Pneumonitis  1  7/154 (4.55%)  7 1/150 (0.67%)  1
Pneumothorax  1  1/154 (0.65%)  1 1/150 (0.67%)  1
Pulmonary alveolar haemorrhage  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Pulmonary embolism  1  2/154 (1.30%)  2 2/150 (1.33%)  2
Pulmonary oedema  1  0/154 (0.00%)  0 2/150 (1.33%)  2
Respiratory failure  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Skin and subcutaneous tissue disorders     
Lichenoid keratosis  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Rash  1  1/154 (0.65%)  1 0/150 (0.00%)  0
Vascular disorders     
Peripheral embolism  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Vasospasm  1  0/154 (0.00%)  0 1/150 (0.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab SOC Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   131/154 (85.06%)      141/150 (94.00%)    
Blood and lymphatic system disorders     
Anaemia  1  20/154 (12.99%)  22 76/150 (50.67%)  93
Leukopenia  1  1/154 (0.65%)  1 10/150 (6.67%)  17
Neutropenia  1  2/154 (1.30%)  4 36/150 (24.00%)  65
Thrombocytopenia  1  2/154 (1.30%)  2 19/150 (12.67%)  30
Endocrine disorders     
Hyperthyroidism  1  11/154 (7.14%)  11 2/150 (1.33%)  3
Hypothyroidism  1  14/154 (9.09%)  14 2/150 (1.33%)  2
Gastrointestinal disorders     
Abdominal pain  1  9/154 (5.84%)  12 10/150 (6.67%)  11
Constipation  1  32/154 (20.78%)  39 33/150 (22.00%)  55
Diarrhoea  1  31/154 (20.13%)  51 32/150 (21.33%)  40
Dyspepsia  1  5/154 (3.25%)  6 9/150 (6.00%)  14
Nausea  1  30/154 (19.48%)  39 68/150 (45.33%)  124
Stomatitis  1  7/154 (4.55%)  7 17/150 (11.33%)  23
Vomiting  1  11/154 (7.14%)  15 36/150 (24.00%)  64
General disorders     
Asthenia  1  10/154 (6.49%)  14 16/150 (10.67%)  29
Chest pain  1  12/154 (7.79%)  12 14/150 (9.33%)  14
Fatigue  1  31/154 (20.13%)  38 53/150 (35.33%)  96
Malaise  1  4/154 (2.60%)  4 12/150 (8.00%)  13
Oedema peripheral  1  16/154 (10.39%)  16 15/150 (10.00%)  19
Pyrexia  1  22/154 (14.29%)  30 13/150 (8.67%)  14
Infections and infestations     
Nasopharyngitis  1  16/154 (10.39%)  17 2/150 (1.33%)  2
Upper respiratory tract infection  1  9/154 (5.84%)  10 5/150 (3.33%)  7
Investigations     
Alanine aminotransferase increased  1  16/154 (10.39%)  17 11/150 (7.33%)  15
Aspartate aminotransferase increased  1  13/154 (8.44%)  15 7/150 (4.67%)  9
Blood alkaline phosphatase increased  1  10/154 (6.49%)  14 4/150 (2.67%)  4
Blood creatinine increased  1  10/154 (6.49%)  11 20/150 (13.33%)  25
Neutrophil count decreased  1  1/154 (0.65%)  1 20/150 (13.33%)  36
Platelet count decreased  1  1/154 (0.65%)  1 19/150 (12.67%)  28
Weight decreased  1  13/154 (8.44%)  14 11/150 (7.33%)  12
White blood cell count decreased  1  1/154 (0.65%)  2 16/150 (10.67%)  22
Metabolism and nutrition disorders     
Decreased appetite  1  30/154 (19.48%)  32 49/150 (32.67%)  67
Hyperglycaemia  1  9/154 (5.84%)  15 9/150 (6.00%)  11
Hypomagnesaemia  1  2/154 (1.30%)  4 13/150 (8.67%)  17
Hyponatraemia  1  8/154 (5.19%)  11 12/150 (8.00%)  13
Musculoskeletal and connective tissue disorders     
Arthralgia  1  24/154 (15.58%)  29 14/150 (9.33%)  15
Back pain  1  20/154 (12.99%)  22 19/150 (12.67%)  22
Muscle spasms  1  8/154 (5.19%)  8 2/150 (1.33%)  2
Musculoskeletal pain  1  10/154 (6.49%)  10 7/150 (4.67%)  8
Pain in extremity  1  6/154 (3.90%)  7 10/150 (6.67%)  13
Nervous system disorders     
Dizziness  1  16/154 (10.39%)  19 12/150 (8.00%)  16
Dysgeusia  1  3/154 (1.95%)  3 18/150 (12.00%)  19
Headache  1  9/154 (5.84%)  14 7/150 (4.67%)  8
Neuropathy peripheral  1  2/154 (1.30%)  2 10/150 (6.67%)  10
Psychiatric disorders     
Insomnia  1  13/154 (8.44%)  14 9/150 (6.00%)  9
Respiratory, thoracic and mediastinal disorders     
Cough  1  26/154 (16.88%)  36 21/150 (14.00%)  24
Dyspnoea  1  34/154 (22.08%)  41 24/150 (16.00%)  29
Haemoptysis  1  10/154 (6.49%)  10 5/150 (3.33%)  5
Hiccups  1  2/154 (1.30%)  2 10/150 (6.67%)  12
Skin and subcutaneous tissue disorders     
Alopecia  1  2/154 (1.30%)  2 13/150 (8.67%)  13
Dry skin  1  13/154 (8.44%)  14 1/150 (0.67%)  1
Pruritus  1  23/154 (14.94%)  31 5/150 (3.33%)  5
Rash  1  21/154 (13.64%)  29 6/150 (4.00%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02142738     History of Changes
Other Study ID Numbers: 3475-024
2014-000323-25 ( EudraCT Number )
142728 ( Registry Identifier: JAPIC )
MK-3475-024 ( Other Identifier: Merck Protocol Number )
First Submitted: May 16, 2014
First Posted: May 20, 2014
Results First Submitted: April 14, 2017
Results First Posted: July 7, 2017
Last Update Posted: February 15, 2019