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Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)

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: NCT01848834
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : June 26, 2017
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cancer
Solid Tumor
Intervention Biological: Pembrolizumab
Enrollment 297
Recruitment Details  
Pre-assignment Details This results disclosure is based on a data cutoff date of 26 April 2016 for Cohorts A and D, and a data cutoff date of 01 Sep 2015 for Cohorts B, B2 and C. As of the data cutoff dates, 33 participants were on treatment in the study. One additional participant was enrolled in Cohort B, but did not receive any study treatment.
Arm/Group Title Cohort A: Triple Negative Breast Cancer Cohort B: Head & Neck Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer Cohort B2: Head & Neck Cancer Expansion
Hide Arm/Group Description Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Period Title: Overall Study
Started 32 61 33 39 132
Treated 32 60 33 39 132
Completed 2 [1] 1 [1] 1 [1] 2 [1] 0 [1]
Not Completed 30 60 32 37 132
Reason Not Completed
Ongoing in Study             0             6             1             0             26
Physician Decision             0             0             0             0             1
Adverse Event             3             8             6             1             15
Complete Response             0             1             0             0             0
Death             0             1             0             0             3
Progressive Disease             27             41             21             36             78
Protocol Violation             0             0             1             0             2
Withdrawal by Subject             0             2             3             0             7
Not Treated             0             1             0             0             0
[1]
Completed means two-year treatment completed
Arm/Group Title Cohort A: Triple Negative Breast Cancer Cohort B: Head & Neck Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer Cohort B2: Head & Neck Cancer Expansion Total
Hide Arm/Group Description Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Total of all reporting groups
Overall Number of Baseline Participants 32 60 33 39 132 296
Hide Baseline Analysis Population Description
The baseline analysis population consisted of all participants who received at least one dose of study treatment. One additional participant was enrolled in Cohort B, but did not receive any study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 60 participants 33 participants 39 participants 132 participants 296 participants
51.9  (12.1) 61.2  (11.3) 68.5  (10.3) 58.3  (13.2) 58.9  (9.7) 59.6  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 60 participants 33 participants 39 participants 132 participants 296 participants
Female
32
 100.0%
11
  18.3%
10
  30.3%
11
  28.2%
22
  16.7%
86
  29.1%
Male
0
   0.0%
49
  81.7%
23
  69.7%
28
  71.8%
110
  83.3%
210
  70.9%
1.Primary Outcome
Title Number of Participants Experiencing Adverse Events (AEs)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
Time Frame Serious AEs: Up to 90 days after last dose of study treatment (Up to 34 months); nonserious AEs: Up to 30 days after last dose of study treatment (Up to 32 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who received ≥1 dose of study treatment.
Arm/Group Title Cohort A: Triple Negative Breast Cancer Cohort B: Head & Neck Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer Cohort B2: Head & Neck Cancer Expansion
Hide Arm/Group Description:
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 32 60 33 39 132
Measure Type: Number
Unit of Measure: Participants
32 58 33 39 130
2.Primary Outcome
Title Number of Participants Discontinuing From Study Treatment Due to an AE
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. Some cases of clinical progression that led to discontinuation of study treatment were captured as AEs that led to discontinuation of study treatment.
Time Frame Up to last dose of study treatment (Up to approximately 31 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all participants who received ≥1 dose of study treatment.
Arm/Group Title Cohort A: Triple Negative Breast Cancer Cohort B: Head & Neck Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer Cohort B2: Head & Neck Cancer Expansion
Hide Arm/Group Description:
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 32 60 33 39 132
Measure Type: Number
Unit of Measure: Participants
6 12 8 2 21
3.Primary Outcome
Title Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B & B2, C, and D)
Hide Description Overall Response Rate (ORR) was defined as the percentage of participants 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 percentages of participants who experienced a CR or PR for Cohort A, Cohorts B and B2 participants, Cohort C and Cohort D are presented. Cohorts A, B, C and D enrolled participants with programmed cell death-ligand 1 (PD-L1) positive tumors; Cohort B2 enrolled participants regardless of PD-L1 expression.
Time Frame Every 8 weeks until disease progression (Up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all Cohort A, B, B2, C and D participants who received ≥1 dose of study treatment.
Arm/Group Title Cohort A: Triple Negative Breast Cancer Cohort B: Head & Neck Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer
Hide Arm/Group Description:
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 32 192 33 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
15.6
(5.3 to 32.8)
17.7
(12.6 to 23.9)
21.2
(9.0 to 38.9)
20.5
(9.3 to 36.5)
4.Primary Outcome
Title Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2
Hide Description ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a 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 percentage of participants who experienced a CR or PR in Cohort B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in a separate outcome measure.
Time Frame Every 8 weeks until disease progression (Up to approximately 14 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.
Arm/Group Title Cohort B2: Head & Neck Cancer Expansion
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
18.2
(12.0 to 25.8)
5.Secondary Outcome
Title Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 HPV-positive Participants
Hide Description ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a 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 percentage of participants who had tumors which were HPV positive and who experienced a CR or PR in the combined Cohorts B2 and B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in a separate outcome measure.
Time Frame Every 8 weeks until disease progression (Up to approximately 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all Cohort B and Cohort B2 HPV-positive participants who received ≥1 dose of study treatment.
Arm/Group Title Cohorts B & B2: Head & Neck Cancer HPV-positive Participants
Hide Arm/Group Description:
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks or pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
21.9
(12.5 to 34.0)
6.Secondary Outcome
Title Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants
Hide Description ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a 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 percentage of participants who were from the Asia Pacific region and experienced a CR or PR in Cohort D is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in separate outcome measures.
Time Frame Every 8 weeks until disease progression (Up to approximately 30 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all Cohort D AP participants who received ≥1 dose of study treatment.
Arm/Group Title Cohort D: Gastric Cancer AP Participants
Hide Arm/Group Description:
Participants who were from the Asia Pacific region received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
21.1
(6.1 to 45.6)
7.Secondary Outcome
Title Overall RECIST 1.1 Response Rate Based on BICR Review, for Participants Previously Treated With Cetuximab and Platinum in Cohorts B and B2
Hide Description ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a 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 percentage of participants who were previously treated with cetuximab and platinum and experienced a CR or PR in the Cohorts B and B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in separate outcome measures.
Time Frame Every 8 weeks until disease progression (Up to approximately 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all Cohort B or B2 participants who progressed following cetuximab and platinum therapy and received ≥1 dose of study treatment.
Arm/Group Title Cohorts B & B2: Head & Neck Cancer
Hide Arm/Group Description:
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks (Cohort B) or pembrolizumab, 200 mg, IV once every 3 weeks (Cohort B2), and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 110
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
14.5
(8.5 to 22.5)
8.Secondary Outcome
Title Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D
Hide Description ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentages of participants who experienced a CR or PR in Cohorts A, B, C and D based on Investigator assessment are presented. ORR per Investigator assessment is presented for Cohort B2 in a separate outcome measure.
Time Frame Every 8 weeks until disease progression (Up to approximately 34 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all Cohort A, B, C and D participants who received ≥1 dose of study treatment.
Arm/Group Title Cohort A: Triple Negative Breast Cancer Cohort B: Head & Neck Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer
Hide Arm/Group Description:
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 32 60 33 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
15.6
(5.3 to 32.8)
16.7
(8.3 to 28.5)
21.2
(9.0 to 38.9)
33.3
(19.1 to 50.2)
9.Secondary Outcome
Title Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohort B2
Hide Description ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentages of participants who experienced a CR or PR in Cohorts A, B, C and D based on Investigator assessment are presented. ORR per Investigator assessment is presented for the other cohorts in a separate outcome measure.
Time Frame Every 8 weeks until disease progression (Up to approximately 14 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.
Arm/Group Title Cohort B2: Head & Neck Cancer Expansion
Hide Arm/Group Description:
Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
19.7
(13.3 to 27.5)
10.Other Pre-specified Outcome
Title Number of Participants With Log Fold Change From Baseline in Cytokines (Interleukin 10 [IL-10]) >1
Hide Description IL-10 is an anti-inflammatory cytokine. The number of participants with a log fold change from Baseline in IL-10 >1 was to be presented. Protocol Amendment 03 (26 May 2015) removed the secondary objective of investigating the relationship between programmed cell death 1 (PD-1) inhibition and up-regulation of cytokines biomarkers predicting response (e.g. IL-10) from the protocol. No data were collected for this outcome measure.
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The population was to consist of all randomized participants who: 1) received ≥1 dose of study treatment and 2) had a baseline IL-10 assessment, and 3) had a post baseline IL-10 assessment. No data were collected for this outcome measure.
Arm/Group Title Cohort A: Triple Negative Breast Cancer Cohort B: Head & Neck Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer Cohort B2: Head & Neck Cancer Expansion
Hide Arm/Group Description:
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Serious AEs: Up to 90 days after last dose of study treatment (up to 34 months); nonserious AEs: Up to 30 days after last dose of study treatment (up to 32 months)
Adverse Event Reporting Description MedDRA 18.1 was used for the head & neck cancer cohorts (Cohorts B and B2) and urothelial cancer cohort (Cohort C). MedDRA 19 was used for the triple negative breast cancer cohort (Cohort A) and gastric cancer cohort (Cohort D).
 
Arm/Group Title Cohort B: Head & Neck Cancer Cohort B2: Head & Neck Cancer Expansion Cohort A: Triple Negative Breast Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer
Hide Arm/Group Description Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 200 mg, IV once every 3 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression. Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
All-Cause Mortality
Cohort B: Head & Neck Cancer Cohort B2: Head & Neck Cancer Expansion Cohort A: Triple Negative Breast Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Cohort B: Head & Neck Cancer Cohort B2: Head & Neck Cancer Expansion Cohort A: Triple Negative Breast Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/60 (45.00%)      56/132 (42.42%)      13/32 (40.63%)      20/33 (60.61%)      16/39 (41.03%)    
Blood and lymphatic system disorders           
Anaemia  1  2/60 (3.33%)  2 1/132 (0.76%)  1 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Anaemia of malignant disease  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Immune thrombocytopenic purpura  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Neutropenia  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Disseminated intravascular coagulation  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Cardiac disorders           
Atrial fibrillation  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Cardiac arrest  1  2/60 (3.33%)  2 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Cardiac failure congestive  1  2/60 (3.33%)  3 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Myocardial infarction  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Pericardial effusion  1  0/60 (0.00%)  0 1/132 (0.76%)  1 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Eye disorders           
Blurred vision  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  1/60 (1.67%)  1 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Colitis  1  0/60 (0.00%)  0 1/132 (0.76%)  2 1/32 (3.13%)  1 1/33 (3.03%)  1 0/39 (0.00%)  0
Constipation  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Diarrhoea  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Gastric ulcer  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Lip swelling  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Mouth haemorrhage  1  1/60 (1.67%)  3 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Nausea  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Oesophageal perforation  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Stomatitis  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Tongue oedema  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  3
Vomiting  1  2/60 (3.33%)  2 2/132 (1.52%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Oesophagitis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Intestinal obstruction  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Large intestine perforation  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Small intestinal obstruction  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  2 0/39 (0.00%)  0
Gastrointestinal haemorrhage  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Oesophageal stenosis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  2
General disorders           
Death  1  1/60 (1.67%)  1 3/132 (2.27%)  3 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Device malfunction  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Face oedema  1  1/60 (1.67%)  1 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Fatigue  1  0/60 (0.00%)  0 1/132 (0.76%)  1 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Localised oedema  1  0/60 (0.00%)  0 2/132 (1.52%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Pyrexia  1  0/60 (0.00%)  0 1/132 (0.76%)  1 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Device dislocation  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Malaise  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Oedema peripheral  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Hepatobiliary disorders           
Cholangitis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Cholangitis acute  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Hepatitis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Hyperbilirubinaemia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Infections and infestations           
Abscess neck  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Bronchitis  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Cellulitis  1  2/60 (3.33%)  2 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Clostridium difficile colitis  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Diverticulitis  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Fascial infection  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Infection  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Infusion site infection  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Otitis media bacterial  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Pneumonia  1  3/60 (5.00%)  4 3/132 (2.27%)  4 0/32 (0.00%)  0 1/33 (3.03%)  1 1/39 (2.56%)  1
Pneumonia influenzal  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Sepsis  1  1/60 (1.67%)  1 1/132 (0.76%)  1 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Sinusitis  1  1/60 (1.67%)  1 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Staphylococcal bacteraemia  1  1/60 (1.67%)  1 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Stoma site infection  1  0/60 (0.00%)  0 3/132 (2.27%)  3 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Streptococcal bacteraemia  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Urinary tract infection  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 3/33 (9.09%)  4 0/39 (0.00%)  0
Urosepsis  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Meningitis aseptic  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Biliary tract infection  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Injury, poisoning and procedural complications           
Arterial injury  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Post procedural haemorrhage  1  1/60 (1.67%)  1 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Head injury  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Post lumbar puncture syndrome  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Spinal compression fracture  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 1/33 (3.03%)  1 0/39 (0.00%)  0
Incisional hernia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Investigations           
Alanine aminotransferase increased  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Aspartate aminotransferase increased  1  1/60 (1.67%)  1 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Hepatic enzyme increased  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Blood fibrinogen decreased  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Metabolism and nutrition disorders           
Decreased appetite  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Diabetic ketoacidosis  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Hypercalcaemia  1  0/60 (0.00%)  0 3/132 (2.27%)  5 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Hyperglycaemia  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Dehydration  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Acidosis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Hyperkalaemia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Hyponatraemia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain  1  0/60 (0.00%)  0 1/132 (0.76%)  1 2/32 (6.25%)  3 0/33 (0.00%)  0 0/39 (0.00%)  0
Fistula discharge  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Musculoskeletal pain  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Pain in extremity  1  1/60 (1.67%)  1 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Pain in jaw  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Myositis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Rhabdomyolysis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal cell carcinoma  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Bone cancer metastatic  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Cancer pain  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Malignant pleural effusion  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Metastases to bone  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Metastatic pain  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Squamous cell carcinoma of skin  1  1/60 (1.67%)  1 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Tumour haemorrhage  1  1/60 (1.67%)  1 2/132 (1.52%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Metastases to peripheral vascular system  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Nervous system disorders           
Carotid artery stenosis  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Cerebrovascular accident  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Encephalopathy  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Lacunar infarction  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Seizure  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Subarachnoid haemorrhage  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Syncope  1  0/60 (0.00%)  0 3/132 (2.27%)  3 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Headache  1  0/60 (0.00%)  0 0/132 (0.00%)  0 2/32 (6.25%)  2 0/33 (0.00%)  0 0/39 (0.00%)  0
Depressed level of consciousness  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Neuromyopathy  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Toxic encephalopathy  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Neuralgia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Psychiatric disorders           
Agitation  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Confusional state  1  2/60 (3.33%)  2 3/132 (2.27%)  3 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 1/33 (3.03%)  2 0/39 (0.00%)  0
Azotaemia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Reproductive system and breast disorders           
Female genital tract fistula  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Apnoea  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Cough  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Dyspnoea  1  1/60 (1.67%)  1 5/132 (3.79%)  5 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Haemoptysis  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Hypoxia  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Interstitial lung disease  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Pleural effusion  1  2/60 (3.33%)  2 2/132 (1.52%)  2 1/32 (3.13%)  1 0/33 (0.00%)  0 1/39 (2.56%)  1
Pneumonia aspiration  1  1/60 (1.67%)  1 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Pneumonitis  1  0/60 (0.00%)  0 2/132 (1.52%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Pneumothorax  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Pulmonary embolism  1  0/60 (0.00%)  0 2/132 (1.52%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Respiratory disorder  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Respiratory distress  1  1/60 (1.67%)  1 3/132 (2.27%)  3 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Respiratory failure  1  4/60 (6.67%)  4 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Upper airway obstruction  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Acute respiratory distress syndrome  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Organising pneumonia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/39 (0.00%)  0
Aspiration  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Pulmonary oedema  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Tracheomalacia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Skin and subcutaneous tissue disorders           
Rash macular  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Skin haemorrhage  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Swelling face  1  0/60 (0.00%)  0 2/132 (1.52%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Stasis dermatitis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Pemphigoid  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/39 (2.56%)  1
Vascular disorders           
Deep vein thrombosis  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Haemorrhage  1  0/60 (0.00%)  0 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Hypotension  1  1/60 (1.67%)  1 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Embolism  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1, 19
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort B: Head & Neck Cancer Cohort B2: Head & Neck Cancer Expansion Cohort A: Triple Negative Breast Cancer Cohort C: Urothelial Cancer Cohort D: Gastric Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/60 (95.00%)      119/132 (90.15%)      30/32 (93.75%)      32/33 (96.97%)      37/39 (94.87%)    
Blood and lymphatic system disorders           
Anaemia  1  19/60 (31.67%)  24 26/132 (19.70%)  29 3/32 (9.38%)  3 7/33 (21.21%)  7 4/39 (10.26%)  5
Lymphopenia  1  5/60 (8.33%)  6 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Neutropenia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  10
Cardiac disorders           
Tachycardia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 2/39 (5.13%)  2
Endocrine disorders           
Hypothyroidism  1  9/60 (15.00%)  10 18/132 (13.64%)  18 0/32 (0.00%)  0 0/33 (0.00%)  0 5/39 (12.82%)  6
Hyperthyroidism  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 3/39 (7.69%)  3
Gastrointestinal disorders           
Abdominal distension  1  4/60 (6.67%)  4 2/132 (1.52%)  2 3/32 (9.38%)  3 0/33 (0.00%)  0 3/39 (7.69%)  3
Constipation  1  15/60 (25.00%)  17 19/132 (14.39%)  19 6/32 (18.75%)  7 11/33 (33.33%)  16 7/39 (17.95%)  9
Diarrhoea  1  13/60 (21.67%)  18 12/132 (9.09%)  13 9/32 (28.13%)  14 3/33 (9.09%)  3 5/39 (12.82%)  5
Dysphagia  1  6/60 (10.00%)  7 14/132 (10.61%)  14 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Nausea  1  15/60 (25.00%)  21 18/132 (13.64%)  18 9/32 (28.13%)  12 9/33 (27.27%)  13 11/39 (28.21%)  11
Oral pain  1  5/60 (8.33%)  5 5/132 (3.79%)  5 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Vomiting  1  12/60 (20.00%)  13 12/132 (9.09%)  12 6/32 (18.75%)  8 6/33 (18.18%)  8 9/39 (23.08%)  10
Abdominal pain  1  0/60 (0.00%)  0 0/132 (0.00%)  0 2/32 (6.25%)  2 5/33 (15.15%)  6 13/39 (33.33%)  16
Dry mouth  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 2/39 (5.13%)  2
Flatulence  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Abdominal discomfort  1  0/30 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 4/39 (10.26%)  5
Abdominal pain upper  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 4/39 (10.26%)  4
Ascites  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 3/39 (7.69%)  3
Dyspepsia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 3/39 (7.69%)  3
Eructation  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Stomatitis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
General disorders           
Asthenia  1  4/60 (6.67%)  4 4/132 (3.03%)  4 0/32 (0.00%)  0 2/33 (6.06%)  2 3/39 (7.69%)  3
Chest pain  1  2/60 (3.33%)  3 9/132 (6.82%)  9 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Chills  1  5/60 (8.33%)  6 8/132 (6.06%)  9 0/32 (0.00%)  0 3/33 (9.09%)  4 2/39 (5.13%)  2
Face oedema  1  5/60 (8.33%)  5 2/132 (1.52%)  2 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Fatigue  1  32/60 (53.33%)  37 55/132 (41.67%)  61 17/32 (53.13%)  22 17/33 (51.52%)  22 12/39 (30.77%)  16
Oedema peripheral  1  7/60 (11.67%)  7 6/132 (4.55%)  6 2/32 (6.25%)  2 11/33 (33.33%)  14 4/39 (10.26%)  4
Pyrexia  1  12/60 (20.00%)  15 21/132 (15.91%)  24 3/32 (9.38%)  4 9/33 (27.27%)  11 4/39 (10.26%)  6
Pain  1  0/60 (0.00%)  0 0/132 (0.00%)  0 2/32 (6.25%)  2 3/33 (9.09%)  3 0/39 (0.00%)  0
Malaise  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Temperature intolerance  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Infections and infestations           
Sinusitis  1  4/60 (6.67%)  5 2/132 (1.52%)  2 0/32 (0.00%)  0 3/33 (9.09%)  3 0/39 (0.00%)  0
Skin infection  1  4/60 (6.67%)  4 4/132 (3.03%)  4 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Upper respiratory tract infection  1  0/60 (0.00%)  0 0/132 (0.00%)  0 3/32 (9.38%)  5 2/33 (6.06%)  3 2/39 (5.13%)  2
Candida infection  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Gingivitis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Urinary tract infection  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 5/33 (15.15%)  6 2/39 (5.13%)  3
Injury, poisoning and procedural complications           
Fall  1  0/60 (0.00%)  0 0/132 (0.00%)  0 4/32 (12.50%)  4 0/33 (0.00%)  0 2/20 (10.00%)  2
Investigations           
Aspartate aminotransferase increased  1  2/60 (3.33%)  3 7/132 (5.30%)  7 5/32 (15.63%)  5 4/33 (12.12%)  4 5/39 (12.82%)  5
Blood creatinine increased  1  4/60 (6.67%)  4 4/132 (3.03%)  4 0/32 (0.00%)  0 9/33 (27.27%)  13 2/39 (5.13%)  3
Lymphocyte count decreased  1  0/60 (0.00%)  0 8/132 (6.06%)  9 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Weight decreased  1  10/60 (16.67%)  10 23/132 (17.42%)  30 0/32 (0.00%)  0 3/33 (9.09%)  3 6/39 (15.38%)  7
Alanine aminotranferase increased  1  0/60 (0.00%)  0 0/132 (0.00%)  0 4/32 (12.50%)  4 3/33 (9.09%)  3 4/39 (10.26%)  4
Platelet count decreased  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 3/33 (9.09%)  3 0/39 (0.00%)  0
Weight increased  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 3/33 (9.09%)  4 0/39 (0.00%)  0
Amylase increased  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Blood alkaline phosphatase increased  1  0/30 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 4/39 (10.26%)  4
Blood bilirubin increased  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  3
Metabolism and nutrition disorders           
Decreased appetite  1  14/60 (23.33%)  15 29/132 (21.97%)  29 2/32 (6.25%)  2 13/33 (39.39%)  13 12/39 (30.77%)  14
Dehydration  1  6/60 (10.00%)  8 8/132 (6.06%)  9 0/32 (0.00%)  0 3/33 (9.09%)  3 0/39 (0.00%)  0
Hypercalcaemia  1  7/60 (11.67%)  10 8/132 (6.06%)  9 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Hyperglycaemia  1  7/60 (11.67%)  14 6/132 (4.55%)  6 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Hypoalbuminaemia  1  4/60 (6.67%)  4 8/132 (6.06%)  8 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Hypocalcaemia  1  4/60 (6.67%)  5 2/132 (1.52%)  2 2/32 (6.25%)  2 0/33 (0.00%)  0 0/39 (0.00%)  0
Hypokalaemia  1  11/60 (18.33%)  26 10/132 (7.58%)  11 0/32 (0.00%)  0 3/33 (9.09%)  3 2/39 (5.13%)  2
Hypomagnesaemia  1  5/60 (8.33%)  5 8/132 (6.06%)  9 0/32 (0.00%)  0 2/33 (6.06%)  3 3/39 (7.69%)  3
Hyponatraemia  1  10/60 (16.67%)  18 12/132 (9.09%)  13 2/32 (6.25%)  2 5/33 (15.15%)  12 2/39 (5.13%)  2
Hypophosphataemia  1  6/60 (10.00%)  8 6/132 (4.55%)  9 2/32 (6.25%)  2 2/33 (6.06%)  5 0/39 (0.00%)  0
Hyperkalaemia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  11/60 (18.33%)  13 15/132 (11.36%)  19 8/32 (25.00%)  12 3/33 (9.09%)  4 6/39 (15.38%)  7
Back pain  1  9/60 (15.00%)  10 11/132 (8.33%)  12 6/32 (18.75%)  6 7/33 (21.21%)  8 4/39 (10.26%)  4
Musculoskeletal chest pain  1  7/60 (11.67%)  9 3/132 (2.27%)  3 7/32 (21.88%)  7 0/33 (0.00%)  0 0/39 (0.00%)  0
Musculoskeletal pain  1  5/60 (8.33%)  5 6/132 (4.55%)  6 2/32 (6.25%)  2 2/33 (6.06%)  2 3/39 (7.69%)  3
Myalgia  1  8/60 (13.33%)  8 7/132 (5.30%)  8 10/32 (31.25%)  12 3/33 (9.09%)  4 3/39 (7.69%)  4
Neck pain  1  3/60 (5.00%)  3 13/132 (9.85%)  13 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Muscular weakness  1  0/60 (0.00%)  0 0/132 (0.00%)  0 2/32 (6.25%)  2 0/33 (0.00%)  0 2/39 (5.13%)  2
Pain in extremity  1  0/60 (0.00%)  0 0/132 (0.00%)  0 4/32 (12.50%)  5 3/33 (9.09%)  4 0/39 (0.00%)  0
Flank pain  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  3 2/39 (5.13%)  2
Groin pain  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 4/33 (12.12%)  4 0/39 (0.00%)  0
Muscle spasms  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 3/33 (9.09%)  3 2/39 (5.13%)  2
Pain in jaw  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Cancer pain  1  0/60 (0.00%)  0 0/132 (0.00%)  0 2/32 (6.25%)  2 0/33 (0.00%)  0 0/39 (0.00%)  0
Nervous system disorders           
Dizziness  1  10/60 (16.67%)  11 7/132 (5.30%)  7 3/32 (9.38%)  4 2/33 (6.06%)  2 4/39 (10.26%)  4
Headache  1  10/60 (16.67%)  12 13/132 (9.85%)  15 2/32 (6.25%)  3 2/33 (6.06%)  2 3/39 (7.69%)  3
Balance disorder  1  0/60 (0.00%)  0 0/132 (0.00%)  0 2/32 (6.25%)  2 0/33 (0.00%)  0 0/39 (0.00%)  0
Depressed level of consciousness  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Peripheral sensory neuropathy  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 3/39 (7.69%)  3
Psychiatric disorders           
Anxiety  1  6/60 (10.00%)  7 4/132 (3.03%)  4 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Insomnia  1  5/60 (8.33%)  6 8/132 (6.06%)  8 2/32 (6.25%)  2 0/33 (0.00%)  0 0/39 (0.00%)  0
Confusional state  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 4/33 (12.12%)  4 0/39 (0.00%)  0
Depression  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Restlessness  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 3/33 (9.09%)  3 0/39 (0.00%)  0
Renal and urinary disorders           
Haematuria  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 3/33 (9.09%)  3 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  9/60 (15.00%)  11 15/132 (11.36%)  16 5/32 (15.63%)  6 3/33 (9.09%)  4 8/39 (20.51%)  9
Dyspnoea  1  13/60 (21.67%)  15 22/132 (16.67%)  22 7/32 (21.88%)  8 7/33 (21.21%)  7 0/39 (0.00%)  0
Oropharyngeal pain  1  6/60 (10.00%)  10 4/132 (3.03%)  5 0/32 (0.00%)  0 0/33 (0.00%)  0 3/39 (7.69%)  3
Pneumonia aspiration  1  4/60 (6.67%)  4 1/132 (0.76%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Productive cough  1  6/60 (10.00%)  7 5/132 (3.79%)  5 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Pleural effusion  1  0/60 (0.00%)  0 0/132 (0.00%)  0 4/32 (12.50%)  5 2/33 (6.06%)  2 0/39 (0.00%)  0
Dyspnoea exertional  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 2/33 (6.06%)  2 0/39 (0.00%)  0
Wheezing  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Skin and subcutaneous tissue disorders           
Dry skin  1  2/60 (3.33%)  2 12/132 (9.09%)  14 2/32 (6.25%)  2 0/33 (0.00%)  0 0/39 (0.00%)  0
Pruritus  1  8/60 (13.33%)  13 13/132 (9.85%)  14 4/32 (12.50%)  5 3/33 (9.09%)  4 6/39 (15.38%)  7
Rash  1  10/60 (16.67%)  11 14/132 (10.61%)  17 4/32 (12.50%)  6 2/33 (6.06%)  2 2/39 (5.13%)  3
Swelling face  1  4/60 (6.67%)  5 7/132 (5.30%)  7 0/32 (0.00%)  0 0/33 (0.00%)  0 0/39 (0.00%)  0
Alopecia  1  0/60 (0.00%)  0 0/132 (0.00%)  0 3/32 (9.38%)  3 2/33 (6.06%)  2 0/39 (0.00%)  0
Erythema  1  0/60 (0.00%)  0 0/132 (0.00%)  0 2/32 (6.25%)  3 0/33 (0.00%)  0 0/39 (0.00%)  0
Hyperhidrosis  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 3/39 (7.69%)  3
Night sweats  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Urticaria  1  0/60 (0.00%)  0 0/132 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/39 (5.13%)  2
Vascular disorders           
Hypotension  1  10/60 (16.67%)  13 7/132 (5.30%)  7 0/32 (0.00%)  0 3/33 (9.09%)  3 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1, 19
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 trial 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
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Publications of Results:
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01848834    
Other Study ID Numbers: 3475-012
2012-005771-14 ( EudraCT Number )
142453 ( Registry Identifier: JAPIC_CTI )
MK-3475-012 ( Other Identifier: Merck Protocol Number )
First Submitted: May 3, 2013
First Posted: May 8, 2013
Results First Submitted: April 7, 2017
Results First Posted: June 26, 2017
Last Update Posted: July 31, 2020