We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03517449
Recruitment Status : Active, not recruiting
First Posted : May 7, 2018
Results First Posted : November 17, 2021
Last Update Posted : October 4, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Endometrial Neoplasms
Interventions Drug: Pembrolizumab
Drug: Lenvatinib
Drug: Paclitaxel
Drug: Doxorubicin
Enrollment 827
Recruitment Details Participants took part in the study at 167 investigative sites in Argentina, Australia, Brazil, Canada, Colombia, France, Germany, Ireland, Israel, Italy, Japan, Korea, Mexico, New Zealand, Poland, Russia, Spain, Taiwan, Turkey, United Kingdom and the United States. Results in this summary are reported based on the primary completion date (26 October 2020) of the study.
Pre-assignment Details A total of 1178 participants were screened, of which 351 were screen failures and 827 were enrolled and randomized, out of which 794 participants were treated.
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Hide Arm/Group Description Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study. Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
Period Title: Overall Study
Started 411 416
Treated 406 388
Completed 0 0
Not Completed 411 416
Reason Not Completed
Death             184             236
Lost to Follow-up             0             2
Withdrawal by Subject             7             26
Participants Ongoing             220             152
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel Total
Hide Arm/Group Description Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study. Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study. Total of all reporting groups
Overall Number of Baseline Participants 411 416 827
Hide Baseline Analysis Population Description
The Intention-to-treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 411 participants 416 participants 827 participants
63.2  (9.1) 63.8  (9.2) 63.5  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 411 participants 416 participants 827 participants
Female
411
 100.0%
416
 100.0%
827
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 411 participants 416 participants 827 participants
Hispanic or Latino
60
  14.6%
73
  17.5%
133
  16.1%
Not Hispanic or Latino
308
  74.9%
287
  69.0%
595
  71.9%
Unknown or Not Reported
43
  10.5%
56
  13.5%
99
  12.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 411 participants 416 participants 827 participants
American Indian or Alaska Native
4
   1.0%
7
   1.7%
11
   1.3%
Asian
85
  20.7%
92
  22.1%
177
  21.4%
Native Hawaiian or Other Pacific Islander
1
   0.2%
0
   0.0%
1
   0.1%
Black or African American
17
   4.1%
14
   3.4%
31
   3.7%
White
261
  63.5%
246
  59.1%
507
  61.3%
More than one race
7
   1.7%
13
   3.1%
20
   2.4%
Unknown or Not Reported
36
   8.8%
44
  10.6%
80
   9.7%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression, as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Time Frame From the date of randomization to the date of the first documentation of disease progression or death, whichever occurred first or up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants.
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Hide Arm/Group Description:
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
Overall Number of Participants Analyzed 411 416
Median (95% Confidence Interval)
Unit of Measure: Months
7.2
(5.7 to 7.6)
3.8
(3.6 to 4.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenvatinib 20 mg + Pembrolizumab 200 mg, Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.47 to 0.66
Estimation Comments Regression, Cox method
2.Primary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from the date of randomization to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the date of data cut-off were censored at the date the participant was last known alive, or date of data cut-off, whichever occurred first.
Time Frame From the date of randomization until the date of death from any cause or up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants.
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Hide Arm/Group Description:
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
Overall Number of Participants Analyzed 411 416
Median (95% Confidence Interval)
Unit of Measure: Months
18.3
(15.2 to 20.5)
11.4
(10.5 to 12.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenvatinib 20 mg + Pembrolizumab 200 mg, Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.51 to 0.75
Estimation Comments Regression, Cox method
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants who had best overall response of either complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time Frame From date of randomization up to first documentation of PD or date of death, whichever occurred first up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants.
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Hide Arm/Group Description:
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
Overall Number of Participants Analyzed 411 416
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
31.9
(27.4 to 36.6)
14.7
(11.4 to 18.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenvatinib 20 mg + Pembrolizumab 200 mg, Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percent
Estimated Value 17.2
Confidence Interval (2-Sided) 95%
11.5 to 22.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Health-Related Quality of Life (HRQoL) Assessed by European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQC30) Score
Hide Description EORTC QLQ-C30 was a questionnaire which included 30 questions that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2023).
Time Frame At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length of either 21 or 28 days), and at the post-treatment visit (up to 5 years and 5 months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Immune-Related Adverse Events (irAEs)
Hide Description TEAEs was defined as AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect. irAE was defined as any unfavorable and unintended immune-related sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Time Frame From the first dose of study drug up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants who received at least 1 dose of study treatment.
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Hide Arm/Group Description:
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
Overall Number of Participants Analyzed 406 388
Measure Type: Count of Participants
Unit of Measure: Participants
Participants With TEAEs
405
  99.8%
386
  99.5%
Participants With SAEs
214
  52.7%
118
  30.4%
Participants With irAEs
273
  67.2%
17
   4.4%
6.Secondary Outcome
Title Percentage of Participants Discontinued Study Treatment Due to TEAEs
Hide Description TEAEs was defined as those AEs that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time Frame From the first dose of study drug up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all randomized participants who received at least 1 dose of study treatment.
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
Hide Arm/Group Description:
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
Overall Number of Participants Analyzed 406 388
Measure Type: Number
Unit of Measure: Percentage of participants
33.0 8.0
7.Secondary Outcome
Title Time to Treatment Failure Due to Toxicity
Hide Description Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date a participant discontinued study treatment due to TEAEs. Data for this outcome measure will be reported after study completion (anticipated study completion date is November 2023).
Time Frame From the date of randomization to the date of discontinuation of study treatment due to TEAEs (up to 5 years 5 months)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib
Hide Description Sparse pharmacokinetic (PK) samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted CL/F for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.
Time Frame Cycle 1 Day 1: 0.5-10 hours post-dose; Cycle 1 Day 15: 0-12 hours post-dose; Cycle 2 Day 1: 0.5-10 hours post-dose (each cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The population pharmacokinetic analysis set includes all the participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm, and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
Overall Number of Participants Analyzed 403
Mean (Standard Deviation)
Unit of Measure: liter per hour (L/h)
4.69  (1.39)
9.Secondary Outcome
Title Model Predicted Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
Hide Description Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Individual predicted AUC for lenvatinib was then derived from the PK model. The data was collected and analyzed for lenvatinib plus pembrolizumab arm only.
Time Frame Cycle 1 Day 1: 0.5-10 hours post-dose; Cycle 1 Day 15: 0-12 hours post-dose; Cycle 2 Day 1: 0.5-10 hours post-dose (each cycle length=21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The population pharmacokinetic analysis set includes all the participants who have received at least 1 dose of study treatment with documented dosing history in the lenvatinib plus pembrolizumab arm, and have measurable plasma levels of lenvatinib. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg
Hide Arm/Group Description:
Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
Overall Number of Participants Analyzed 403
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
4134  (1350)
Time Frame From the first dose of study drug up to data cutoff date 26 October 2020 (up to approximately 2 years 5 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice: (TPC) Doxorubicin or Paclitaxel
Hide Arm/Group Description Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study. Participants with EC received either doxorubicin 60 mg/m^2 intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
All-Cause Mortality
Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice: (TPC) Doxorubicin or Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   184/406 (45.32%)   236/388 (60.82%) 
Hide Serious Adverse Events
Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice: (TPC) Doxorubicin or Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   214/406 (52.71%)   118/388 (30.41%) 
Blood and lymphatic system disorders     
Anaemia  1  1/406 (0.25%)  9/388 (2.32%) 
Febrile bone marrow aplasia  1  0/406 (0.00%)  1/388 (0.26%) 
Febrile neutropenia  1  2/406 (0.49%)  16/388 (4.12%) 
Leukocytosis  1  0/406 (0.00%)  1/388 (0.26%) 
Leukopenia  1  0/406 (0.00%)  2/388 (0.52%) 
Neutropenia  1  1/406 (0.25%)  7/388 (1.80%) 
Neutrophilia  1  0/406 (0.00%)  1/388 (0.26%) 
Pancytopenia  1  1/406 (0.25%)  0/388 (0.00%) 
Thrombocytopenia  1  1/406 (0.25%)  1/388 (0.26%) 
Thrombotic microangiopathy  1  1/406 (0.25%)  0/388 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  2/406 (0.49%)  0/388 (0.00%) 
Acute myocardial infarction  1  3/406 (0.74%)  0/388 (0.00%) 
Atrial fibrillation  1  1/406 (0.25%)  2/388 (0.52%) 
Bundle branch block left  1  1/406 (0.25%)  0/388 (0.00%) 
Cardiac failure  1  0/406 (0.00%)  3/388 (0.77%) 
Cardiac failure congestive  1  0/406 (0.00%)  2/388 (0.52%) 
Cardiogenic shock  1  0/406 (0.00%)  2/388 (0.52%) 
Left ventricular dysfunction  1  0/406 (0.00%)  1/388 (0.26%) 
Myocardial infarction  1  1/406 (0.25%)  0/388 (0.00%) 
Myocarditis  1  1/406 (0.25%)  0/388 (0.00%) 
Pericardial effusion  1  1/406 (0.25%)  0/388 (0.00%) 
Right ventricular dysfunction  1  1/406 (0.25%)  0/388 (0.00%) 
Sinus tachycardia  1  1/406 (0.25%)  0/388 (0.00%) 
Stress cardiomyopathy  1  1/406 (0.25%)  0/388 (0.00%) 
Supraventricular tachycardia  1  0/406 (0.00%)  2/388 (0.52%) 
Toxic cardiomyopathy  1  0/406 (0.00%)  1/388 (0.26%) 
Ventricular fibrillation  1  1/406 (0.25%)  0/388 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  3/406 (0.74%)  0/388 (0.00%) 
Adrenocorticotropic hormone deficiency  1  1/406 (0.25%)  0/388 (0.00%) 
Hyperthyroidism  1  3/406 (0.74%)  0/388 (0.00%) 
Hypophysitis  1  1/406 (0.25%)  0/388 (0.00%) 
Hypothyroidism  1  2/406 (0.49%)  0/388 (0.00%) 
Eye disorders     
Iridocyclitis  1  1/406 (0.25%)  0/388 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  4/406 (0.99%)  1/388 (0.26%) 
Abdominal pain lower  1  1/406 (0.25%)  0/388 (0.00%) 
Anal fissure  1  1/406 (0.25%)  0/388 (0.00%) 
Ascites  1  2/406 (0.49%)  2/388 (0.52%) 
Colitis  1  7/406 (1.72%)  1/388 (0.26%) 
Colonic fistula  1  0/406 (0.00%)  2/388 (0.52%) 
Constipation  1  3/406 (0.74%)  0/388 (0.00%) 
Diarrhoea  1  10/406 (2.46%)  3/388 (0.77%) 
Diverticular perforation  1  1/406 (0.25%)  0/388 (0.00%) 
Duodenal obstruction  1  0/406 (0.00%)  1/388 (0.26%) 
Enterocolitis  1  1/406 (0.25%)  0/388 (0.00%) 
Gastritis erosive  1  1/406 (0.25%)  0/388 (0.00%) 
Gastrointestinal haemorrhage  1  2/406 (0.49%)  0/388 (0.00%) 
Gastrointestinal perforation  1  2/406 (0.49%)  0/388 (0.00%) 
Gastrointestinal toxicity  1  0/406 (0.00%)  1/388 (0.26%) 
Gastrooesophageal reflux disease  1  1/406 (0.25%)  0/388 (0.00%) 
Ileus  1  4/406 (0.99%)  0/388 (0.00%) 
Immune-mediated pancreatitis  1  1/406 (0.25%)  0/388 (0.00%) 
Intestinal fistula  1  1/406 (0.25%)  0/388 (0.00%) 
Intestinal obstruction * 1  5/406 (1.23%)  3/388 (0.77%) 
Intestinal perforation  1  3/406 (0.74%)  0/388 (0.00%) 
Large intestinal obstruction  1  1/406 (0.25%)  0/388 (0.00%) 
Large intestine perforation  1  2/406 (0.49%)  0/388 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/406 (0.25%)  0/388 (0.00%) 
Lower gastrointestinal perforation  1  1/406 (0.25%)  0/388 (0.00%) 
Malignant gastrointestinal obstruction  1  1/406 (0.25%)  0/388 (0.00%) 
Mechanical ileus  1  1/406 (0.25%)  0/388 (0.00%) 
Nausea  1  3/406 (0.74%)  1/388 (0.26%) 
Pancreatitis acute  1  2/406 (0.49%)  0/388 (0.00%) 
Proctalgia  1  1/406 (0.25%)  0/388 (0.00%) 
Rectal perforation  1  1/406 (0.25%)  0/388 (0.00%) 
Small intestinal obstruction  1  3/406 (0.74%)  2/388 (0.52%) 
Stomatitis  1  0/406 (0.00%)  1/388 (0.26%) 
Subileus  1  2/406 (0.49%)  1/388 (0.26%) 
Umbilical hernia  1  1/406 (0.25%)  0/388 (0.00%) 
Vomiting  1  9/406 (2.22%)  3/388 (0.77%) 
General disorders     
Asthenia  1  3/406 (0.74%)  2/388 (0.52%) 
Catheter site inflammation  1  0/406 (0.00%)  1/388 (0.26%) 
Condition aggravated  1  0/406 (0.00%)  1/388 (0.26%) 
Death  1  5/406 (1.23%)  3/388 (0.77%) 
Device related thrombosis  1  1/406 (0.25%)  0/388 (0.00%) 
Fatigue  1  2/406 (0.49%)  0/388 (0.00%) 
General physical health deterioration  1  3/406 (0.74%)  1/388 (0.26%) 
Generalised oedema  1  2/406 (0.49%)  0/388 (0.00%) 
Hyperpyrexia  1  0/406 (0.00%)  1/388 (0.26%) 
Mucosal inflammation  1  1/406 (0.25%)  0/388 (0.00%) 
Multiple organ dysfunction syndrome  1  1/406 (0.25%)  2/388 (0.52%) 
Oedema peripheral  1  1/406 (0.25%)  1/388 (0.26%) 
Perforated ulcer  1  1/406 (0.25%)  0/388 (0.00%) 
Pyrexia  1  8/406 (1.97%)  3/388 (0.77%) 
Hepatobiliary disorders     
Bile duct stone  1  1/406 (0.25%)  0/388 (0.00%) 
Biliary obstruction  1  1/406 (0.25%)  0/388 (0.00%) 
Cholangitis  1  3/406 (0.74%)  0/388 (0.00%) 
Cholecystitis  1  7/406 (1.72%)  0/388 (0.00%) 
Cholecystitis acute  1  1/406 (0.25%)  0/388 (0.00%) 
Hepatic failure  1  1/406 (0.25%)  0/388 (0.00%) 
Hepatic function abnormal  1  2/406 (0.49%)  0/388 (0.00%) 
Hepatitis  1  1/406 (0.25%)  0/388 (0.00%) 
Hepatobiliary disease  1  0/406 (0.00%)  1/388 (0.26%) 
Hepatotoxicity  1  1/406 (0.25%)  0/388 (0.00%) 
Immune-mediated hepatitis  1  2/406 (0.49%)  0/388 (0.00%) 
Liver disorder  1  2/406 (0.49%)  0/388 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  1/406 (0.25%)  0/388 (0.00%) 
Anaphylactic shock  1  1/406 (0.25%)  0/388 (0.00%) 
Hypersensitivity  1  3/406 (0.74%)  0/388 (0.00%) 
Infections and infestations     
Abdominal sepsis  1  0/406 (0.00%)  1/388 (0.26%) 
Appendicitis  1  2/406 (0.49%)  0/388 (0.00%) 
Appendicitis perforated  1  1/406 (0.25%)  0/388 (0.00%) 
Arthritis bacterial  1  1/406 (0.25%)  0/388 (0.00%) 
Bacteraemia  1  1/406 (0.25%)  2/388 (0.52%) 
Bacterial infection  1  1/406 (0.25%)  0/388 (0.00%) 
Cellulitis  1  0/406 (0.00%)  2/388 (0.52%) 
Cystitis  1  1/406 (0.25%)  0/388 (0.00%) 
Device related infection  1  2/406 (0.49%)  2/388 (0.52%) 
Diarrhoea infectious  1  1/406 (0.25%)  0/388 (0.00%) 
Encephalitis  1  1/406 (0.25%)  0/388 (0.00%) 
Escherichia bacteraemia  1  1/406 (0.25%)  0/388 (0.00%) 
Gastroenteritis  1  3/406 (0.74%)  1/388 (0.26%) 
Gastroenteritis Escherichia coli  1  1/406 (0.25%)  0/388 (0.00%) 
Gastroenteritis norovirus  1  1/406 (0.25%)  0/388 (0.00%) 
Infected fistula  1  1/406 (0.25%)  0/388 (0.00%) 
Infection  1  2/406 (0.49%)  1/388 (0.26%) 
Influenza  1  2/406 (0.49%)  2/388 (0.52%) 
Lower respiratory tract infection  1  1/406 (0.25%)  0/388 (0.00%) 
Meningitis bacterial  1  1/406 (0.25%)  0/388 (0.00%) 
Oesophageal candidiasis  1  0/406 (0.00%)  1/388 (0.26%) 
Pelvic abscess  1  0/406 (0.00%)  1/388 (0.26%) 
Peritonitis  1  2/406 (0.49%)  0/388 (0.00%) 
Pneumonia  1  6/406 (1.48%)  3/388 (0.77%) 
Postoperative wound infection  1  3/406 (0.74%)  0/388 (0.00%) 
Psoas abscess  1  1/406 (0.25%)  0/388 (0.00%) 
Pyelonephritis  1  1/406 (0.25%)  1/388 (0.26%) 
Pyelonephritis acute  1  0/406 (0.00%)  1/388 (0.26%) 
Retroperitoneal abscess  1  0/406 (0.00%)  1/388 (0.26%) 
Sepsis  1  5/406 (1.23%)  5/388 (1.29%) 
Septic shock  1  0/406 (0.00%)  1/388 (0.26%) 
Sialoadenitis  1  1/406 (0.25%)  0/388 (0.00%) 
Sinusitis  1  1/406 (0.25%)  0/388 (0.00%) 
Skin infection  1  1/406 (0.25%)  0/388 (0.00%) 
Staphylococcal bacteraemia  1  1/406 (0.25%)  0/388 (0.00%) 
Tonsillitis  1  1/406 (0.25%)  0/388 (0.00%) 
Upper respiratory tract infection  1  1/406 (0.25%)  0/388 (0.00%) 
Urinary tract infection  1  13/406 (3.20%)  2/388 (0.52%) 
Urosepsis  1  1/406 (0.25%)  2/388 (0.52%) 
Vaginal abscess  1  1/406 (0.25%)  0/388 (0.00%) 
Vaginal infection  1  1/406 (0.25%)  0/388 (0.00%) 
Wound infection  1  1/406 (0.25%)  0/388 (0.00%) 
Injury, poisoning and procedural complications     
Craniocerebral injury  1  1/406 (0.25%)  0/388 (0.00%) 
Gastroenteritis radiation  1  1/406 (0.25%)  0/388 (0.00%) 
Postoperative ileus  1  1/406 (0.25%)  0/388 (0.00%) 
Radius fracture  1  0/406 (0.00%)  1/388 (0.26%) 
Skull fractured base  1  1/406 (0.25%)  0/388 (0.00%) 
Subdural haematoma  1  0/406 (0.00%)  1/388 (0.26%) 
Vascular procedure complication  1  0/406 (0.00%)  1/388 (0.26%) 
Wound dehiscence  1  1/406 (0.25%)  0/388 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/406 (0.00%)  1/388 (0.26%) 
Aspartate aminotransferase increased  1  0/406 (0.00%)  1/388 (0.26%) 
Blood alkaline phosphatase increased  1  0/406 (0.00%)  1/388 (0.26%) 
Blood creatine phosphokinase increased  1  1/406 (0.25%)  0/388 (0.00%) 
Blood creatinine increased  1  1/406 (0.25%)  0/388 (0.00%) 
ECG signs of myocardial ischaemia  1  1/406 (0.25%)  0/388 (0.00%) 
Ejection fraction decreased  1  0/406 (0.00%)  1/388 (0.26%) 
Electrocardiogram QT prolonged  1  1/406 (0.25%)  0/388 (0.00%) 
Lipase increased  1  1/406 (0.25%)  0/388 (0.00%) 
Transaminases increased  1  1/406 (0.25%)  0/388 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  9/406 (2.22%)  0/388 (0.00%) 
Dehydration  1  5/406 (1.23%)  1/388 (0.26%) 
Diabetes mellitus  1  1/406 (0.25%)  0/388 (0.00%) 
Diabetic ketoacidosis  1  1/406 (0.25%)  0/388 (0.00%) 
Electrolyte imbalance  1  1/406 (0.25%)  0/388 (0.00%) 
Hypercalcaemia  1  1/406 (0.25%)  1/388 (0.26%) 
Hyperglycaemia  1  2/406 (0.49%)  0/388 (0.00%) 
Hypochloraemia  1  0/406 (0.00%)  1/388 (0.26%) 
Hypoglycaemia  1  1/406 (0.25%)  0/388 (0.00%) 
Hypokalaemia  1  3/406 (0.74%)  1/388 (0.26%) 
Hypomagnesaemia  1  1/406 (0.25%)  0/388 (0.00%) 
Hyponatraemia  1  2/406 (0.49%)  2/388 (0.52%) 
Hypophosphataemia  1  0/406 (0.00%)  1/388 (0.26%) 
Malnutrition  1  1/406 (0.25%)  0/388 (0.00%) 
Type 1 diabetes mellitus  1  3/406 (0.74%)  0/388 (0.00%) 
Type 2 diabetes mellitus  1  0/406 (0.00%)  1/388 (0.26%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/406 (0.25%)  0/388 (0.00%) 
Arthritis  1  2/406 (0.49%)  0/388 (0.00%) 
Back pain  1  1/406 (0.25%)  0/388 (0.00%) 
Bone pain  1  0/406 (0.00%)  1/388 (0.26%) 
Fistula  1  1/406 (0.25%)  0/388 (0.00%) 
Myalgia  1  1/406 (0.25%)  0/388 (0.00%) 
Myositis  1  2/406 (0.49%)  0/388 (0.00%) 
Pain in extremity  1  2/406 (0.49%)  0/388 (0.00%) 
Pathological fracture  1  0/406 (0.00%)  1/388 (0.26%) 
Periarthritis  1  1/406 (0.25%)  0/388 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma  1  0/406 (0.00%)  1/388 (0.26%) 
Myelodysplastic syndrome  1  1/406 (0.25%)  0/388 (0.00%) 
Plasma cell myeloma  1  1/406 (0.25%)  0/388 (0.00%) 
Tumour pain  1  0/406 (0.00%)  1/388 (0.26%) 
Nervous system disorders     
Cerebral haemorrhage  1  1/406 (0.25%)  0/388 (0.00%) 
Cerebral infarction  1  1/406 (0.25%)  0/388 (0.00%) 
Cerebrovascular accident  1  2/406 (0.49%)  3/388 (0.77%) 
Encephalitis autoimmune  1  1/406 (0.25%)  0/388 (0.00%) 
Encephalopathy  1  0/406 (0.00%)  1/388 (0.26%) 
Haemorrhage intracranial  1  1/406 (0.25%)  0/388 (0.00%) 
Haemorrhagic stroke  1  1/406 (0.25%)  0/388 (0.00%) 
Headache  1  2/406 (0.49%)  0/388 (0.00%) 
Migraine  1  1/406 (0.25%)  0/388 (0.00%) 
Myasthenia gravis  1  1/406 (0.25%)  0/388 (0.00%) 
Nervous system disorder  1  1/406 (0.25%)  0/388 (0.00%) 
Neuralgia  1  1/406 (0.25%)  0/388 (0.00%) 
Optic neuritis  1  1/406 (0.25%)  0/388 (0.00%) 
Seizure  1  0/406 (0.00%)  2/388 (0.52%) 
Syncope  1  1/406 (0.25%)  2/388 (0.52%) 
Tremor  1  1/406 (0.25%)  0/388 (0.00%) 
Product Issues     
Device dislocation  1  0/406 (0.00%)  1/388 (0.26%) 
Psychiatric disorders     
Anxiety  1  1/406 (0.25%)  1/388 (0.26%) 
Assisted suicide  1  1/406 (0.25%)  0/388 (0.00%) 
Confusional state  1  1/406 (0.25%)  0/388 (0.00%) 
Delirium  1  1/406 (0.25%)  1/388 (0.26%) 
Renal and urinary disorders     
Acute kidney injury  1  8/406 (1.97%)  3/388 (0.77%) 
Autoimmune nephritis  1  1/406 (0.25%)  0/388 (0.00%) 
Haematuria  1  1/406 (0.25%)  1/388 (0.26%) 
Haemorrhage urinary tract  1  1/406 (0.25%)  0/388 (0.00%) 
Hydronephrosis  1  1/406 (0.25%)  0/388 (0.00%) 
Nephrolithiasis  1  0/406 (0.00%)  1/388 (0.26%) 
Renal failure  1  3/406 (0.74%)  1/388 (0.26%) 
Renal injury  1  1/406 (0.25%)  0/388 (0.00%) 
Urinary tract obstruction  1  1/406 (0.25%)  0/388 (0.00%) 
Urogenital fistula  1  1/406 (0.25%)  1/388 (0.26%) 
Reproductive system and breast disorders     
Female genital tract fistula  1  3/406 (0.74%)  1/388 (0.26%) 
Metrorrhagia  1  1/406 (0.25%)  0/388 (0.00%) 
Uterine haemorrhage  1  1/406 (0.25%)  0/388 (0.00%) 
Vaginal haemorrhage  1  3/406 (0.74%)  0/388 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  0/406 (0.00%)  1/388 (0.26%) 
Dyspnoea  1  2/406 (0.49%)  1/388 (0.26%) 
Dyspnoea exertional  1  0/406 (0.00%)  1/388 (0.26%) 
Epistaxis  1  2/406 (0.49%)  0/388 (0.00%) 
Pleural effusion  1  1/406 (0.25%)  1/388 (0.26%) 
Pneumonitis  1  3/406 (0.74%)  0/388 (0.00%) 
Pulmonary embolism  1  4/406 (0.99%)  5/388 (1.29%) 
Pulmonary hypertension  1  1/406 (0.25%)  0/388 (0.00%) 
Respiratory distress  1  0/406 (0.00%)  1/388 (0.26%) 
Respiratory failure  1  1/406 (0.25%)  3/388 (0.77%) 
Skin and subcutaneous tissue disorders     
Drug eruption  1  1/406 (0.25%)  0/388 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/406 (0.25%)  0/388 (0.00%) 
Rash  1  1/406 (0.25%)  0/388 (0.00%) 
Rash macular  1  1/406 (0.25%)  0/388 (0.00%) 
Stasis dermatitis  1  1/406 (0.25%)  0/388 (0.00%) 
Stevens-Johnson syndrome  1  1/406 (0.25%)  0/388 (0.00%) 
Toxic skin eruption  1  1/406 (0.25%)  0/388 (0.00%) 
Umbilical haemorrhage  1  0/406 (0.00%)  1/388 (0.26%) 
Vascular disorders     
Aortic thrombosis  1  1/406 (0.25%)  0/388 (0.00%) 
Deep vein thrombosis  1  1/406 (0.25%)  2/388 (0.52%) 
Hypertension  1  17/406 (4.19%)  0/388 (0.00%) 
Hypotension  1  2/406 (0.49%)  0/388 (0.00%) 
Jugular vein thrombosis  1  1/406 (0.25%)  0/388 (0.00%) 
Pelvic venous thrombosis  1  0/406 (0.00%)  1/388 (0.26%) 
Thrombosis  1  1/406 (0.25%)  0/388 (0.00%) 
Vasculitis  1  1/406 (0.25%)  0/388 (0.00%) 
1
Term from vocabulary, MedDRA Version 23.1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenvatinib 20 mg + Pembrolizumab 200 mg Treatment of Physician's Choice: (TPC) Doxorubicin or Paclitaxel
Affected / at Risk (%) Affected / at Risk (%)
Total   404/406 (99.51%)   379/388 (97.68%) 
Blood and lymphatic system disorders     
Anaemia  1  105/406 (25.86%)  181/388 (46.65%) 
Leukopenia  1  28/406 (6.90%)  49/388 (12.63%) 
Lymphopenia  1  25/406 (6.16%)  30/388 (7.73%) 
Neutropenia  1  29/406 (7.14%)  124/388 (31.96%) 
Thrombocytopenia  1  43/406 (10.59%)  25/388 (6.44%) 
Endocrine disorders     
Hyperthyroidism  1  44/406 (10.84%)  4/388 (1.03%) 
Hypothyroidism  1  231/406 (56.90%)  3/388 (0.77%) 
Gastrointestinal disorders     
Abdominal pain  1  79/406 (19.46%)  52/388 (13.40%) 
Abdominal pain upper  1  53/406 (13.05%)  27/388 (6.96%) 
Constipation  1  104/406 (25.62%)  96/388 (24.74%) 
Diarrhoea  1  215/406 (52.96%)  75/388 (19.33%) 
Dry mouth  1  40/406 (9.85%)  11/388 (2.84%) 
Dyspepsia  1  27/406 (6.65%)  19/388 (4.90%) 
Gastritis  1  21/406 (5.17%)  2/388 (0.52%) 
Gastrooesophageal reflux disease  1  27/406 (6.65%)  8/388 (2.06%) 
Haemorrhoids  1  23/406 (5.67%)  7/388 (1.80%) 
Nausea  1  200/406 (49.26%)  178/388 (45.88%) 
Stomatitis  1  78/406 (19.21%)  46/388 (11.86%) 
Vomiting  1  145/406 (35.71%)  79/388 (20.36%) 
General disorders     
Asthenia  1  94/406 (23.15%)  93/388 (23.97%) 
Fatigue  1  132/406 (32.51%)  107/388 (27.58%) 
Malaise  1  25/406 (6.16%)  19/388 (4.90%) 
Mucosal inflammation  1  48/406 (11.82%)  38/388 (9.79%) 
Oedema peripheral  1  48/406 (11.82%)  35/388 (9.02%) 
Pyrexia  1  54/406 (13.30%)  26/388 (6.70%) 
Infections and infestations     
Nasopharyngitis  1  14/406 (3.45%)  24/388 (6.19%) 
Urinary tract infection  1  95/406 (23.40%)  38/388 (9.79%) 
Investigations     
Alanine aminotransferase increased  1  86/406 (21.18%)  19/388 (4.90%) 
Amylase increased  1  29/406 (7.14%)  5/388 (1.29%) 
Aspartate aminotransferase increased  1  80/406 (19.70%)  16/388 (4.12%) 
Blood alkaline phosphatase increased  1  50/406 (12.32%)  14/388 (3.61%) 
Blood bilirubin increased  1  22/406 (5.42%)  7/388 (1.80%) 
Blood cholesterol increased  1  34/406 (8.37%)  7/388 (1.80%) 
Blood creatinine increased  1  44/406 (10.84%)  10/388 (2.58%) 
Blood thyroid stimulating hormone increased  1  52/406 (12.81%)  1/388 (0.26%) 
Lipase increased  1  44/406 (10.84%)  8/388 (2.06%) 
Lymphocyte count decreased  1  17/406 (4.19%)  23/388 (5.93%) 
Neutrophil count decreased  1  22/406 (5.42%)  94/388 (24.23%) 
Platelet count decreased  1  50/406 (12.32%)  22/388 (5.67%) 
Weight decreased  1  138/406 (33.99%)  22/388 (5.67%) 
White blood cell count decreased  1  20/406 (4.93%)  60/388 (15.46%) 
Metabolism and nutrition disorders     
Decreased appetite  1  174/406 (42.86%)  82/388 (21.13%) 
Dehydration  1  21/406 (5.17%)  7/388 (1.80%) 
Hypercholesterolaemia  1  24/406 (5.91%)  7/388 (1.80%) 
Hyperglycaemia  1  36/406 (8.87%)  19/388 (4.90%) 
Hypertriglyceridaemia  1  51/406 (12.56%)  11/388 (2.84%) 
Hypoalbuminaemia  1  37/406 (9.11%)  18/388 (4.64%) 
Hypokalaemia * 1  52/406 (12.81%)  26/388 (6.70%) 
Hypomagnesaemia  1  71/406 (17.49%)  26/388 (6.70%) 
Hyponatraemia  1  34/406 (8.37%)  16/388 (4.12%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  123/406 (30.30%)  31/388 (7.99%) 
Back pain  1  48/406 (11.82%)  29/388 (7.47%) 
Myalgia  1  71/406 (17.49%)  19/388 (4.90%) 
Pain in extremity  1  44/406 (10.84%)  21/388 (5.41%) 
Nervous system disorders     
Dizziness  1  42/406 (10.34%)  22/388 (5.67%) 
Dysgeusia  1  40/406 (9.85%)  27/388 (6.96%) 
Headache  1  99/406 (24.38%)  34/388 (8.76%) 
Neuropathy peripheral  1  16/406 (3.94%)  22/388 (5.67%) 
Psychiatric disorders     
Insomnia  1  33/406 (8.13%)  20/388 (5.15%) 
Renal and urinary disorders     
Dysuria  1  22/406 (5.42%)  11/388 (2.84%) 
Proteinuria  1  117/406 (28.82%)  11/388 (2.84%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  53/406 (13.05%)  51/388 (13.14%) 
Dysphonia  1  93/406 (22.91%)  2/388 (0.52%) 
Dyspnoea  1  44/406 (10.84%)  41/388 (10.57%) 
Epistaxis  1  31/406 (7.64%)  10/388 (2.58%) 
Oropharyngeal pain  1  22/406 (5.42%)  9/388 (2.32%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  22/406 (5.42%)  120/388 (30.93%) 
Dry skin  1  28/406 (6.90%)  11/388 (2.84%) 
Palmar-plantar erythrodysaesthesia syndrome  1  86/406 (21.18%)  3/388 (0.77%) 
Pruritus  1  42/406 (10.34%)  12/388 (3.09%) 
Rash  1  61/406 (15.02%)  13/388 (3.35%) 
Vascular disorders     
Hypertension  1  250/406 (61.58%)  20/388 (5.15%) 
1
Term from vocabulary, MedDRA Version 23.1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eisai Medical Information
Organization: Eisai Inc.
Phone: 1-888-274-2378
EMail: esi_oncmedinfo@eisai.com
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03517449    
Other Study ID Numbers: E7080-G000-309
2017-004387-35 ( EudraCT Number )
MK3475-775 ( Other Identifier: Merck Protocol Number )
First Submitted: April 25, 2018
First Posted: May 7, 2018
Results First Submitted: October 19, 2021
Results First Posted: November 17, 2021
Last Update Posted: October 4, 2022