Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012) (NCT NCT01848834)
NCT ID: NCT01848834
Last Updated: 2021-06-28
Results Overview
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 was presented for the first course pembrolizumab treatment per protocol.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
297 participants
Primary outcome timeframe
Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)
Results posted on
2021-06-28
Participant Flow
All allocated participants through end of trial (EOT) analysis cutoff date of 30 June 2020.
Participant milestones
| Measure |
Cohort A: Triple Negative Breast Cancer
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.
|
Cohort B: Head & Neck Cancer
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.
|
Cohort C: Urothelial Cancer
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.
|
Cohort D: Gastric Cancer
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 Study
STARTED
|
32
|
61
|
33
|
39
|
132
|
|
Overall Study
Treated
|
32
|
60
|
33
|
39
|
132
|
|
Overall Study
COMPLETED
|
13
|
13
|
9
|
13
|
38
|
|
Overall Study
NOT COMPLETED
|
19
|
48
|
24
|
26
|
94
|
Reasons for withdrawal
| Measure |
Cohort A: Triple Negative Breast Cancer
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.
|
Cohort B: Head & Neck Cancer
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.
|
Cohort C: Urothelial Cancer
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.
|
Cohort D: Gastric Cancer
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 Study
Adverse Event
|
3
|
11
|
3
|
5
|
9
|
|
Overall Study
Death
|
2
|
11
|
1
|
8
|
27
|
|
Overall Study
Excluded Medication
|
5
|
4
|
3
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
3
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
3
|
4
|
0
|
11
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
13
|
10
|
6
|
36
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-012/KEYNOTE-012)
Baseline characteristics by cohort
| Measure |
Cohort A: Triple Negative Breast Cancer
n=32 Participants
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.
|
Cohort B: Head & Neck Cancer
n=61 Participants
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.
|
Cohort C: Urothelial Cancer
n=33 Participants
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.
|
Cohort D: Gastric Cancer
n=39 Participants
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.
|
Cohort B2: Head & Neck Cancer Expansion
n=132 Participants
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
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.9 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
61.5 Years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
68.5 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
58.9 Years
STANDARD_DEVIATION 9.7 • n=21 Participants
|
59.7 Years
STANDARD_DEVIATION 11.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
87 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
210 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
255 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
223 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Serious AEs: Up to 90 days after last dose of treatment (Up to 28 months); nonserious AEs: Up to 30 days after last dose of treatment (Up to 26 months) - through final analysis (FA) cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)Population: The population consisted of all participants who received ≥1 dose of study treatment.
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 was presented for the first course pembrolizumab treatment per protocol.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=32 Participants
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.
|
Cohort B: Head & Neck Cancer
n=60 Participants
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.
|
Cohort C: Urothelial Cancer
n=33 Participants
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.
|
Cohort D: Gastric Cancer
n=39 Participants
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.
|
Cohort B2: Head & Neck Cancer Expansion
n=132 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
32 Participants
|
58 Participants
|
33 Participants
|
39 Participants
|
130 Participants
|
PRIMARY outcome
Timeframe: Up to last dose of study treatment (Up to approximately 25 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, B2, D) & 01 Sep 2015 (Cohort C)Population: The population consisted of all participants who received ≥1 dose of study treatment.
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 unfavourable 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. Some cases of clinical progression that led to discontinuation of study treatment were captured as AEs that led to discontinuation of study treatment. The number of participants who discontinued study treatment due to an AE was presented for the first course pembrolizumab treatment per protocol.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=32 Participants
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.
|
Cohort B: Head & Neck Cancer
n=60 Participants
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.
|
Cohort C: Urothelial Cancer
n=33 Participants
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.
|
Cohort D: Gastric Cancer
n=39 Participants
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.
|
Cohort B2: Head & Neck Cancer Expansion
n=132 Participants
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.
|
|---|---|---|---|---|---|
|
Number of Participants Discontinuing From Study Treatment Due to an AE
|
6 Participants
|
12 Participants
|
8 Participants
|
2 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)Population: The population consisted of Cohorts A, B, C and D participants who received ≥1 dose of study treatment.
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 percentage of participants who experienced a CR or PR for Cohorts A, B, C and D participants was presented for the first course of pembrolizumab treatment per protocol. Cohorts A, B, C and D enrolled participants with programmed cell death-ligand 1 (PD-L1) positive tumors.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=32 Participants
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.
|
Cohort B: Head & Neck Cancer
n=60 Participants
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.
|
Cohort C: Urothelial Cancer
n=33 Participants
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.
|
Cohort D: Gastric Cancer
n=39 Participants
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 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, C, and D)
|
15.6 Percentage of Participants
Interval 5.3 to 32.8
|
16.7 Percentage of Participants
Interval 8.3 to 28.5
|
21.2 Percentage of Participants
Interval 9.0 to 38.9
|
20.5 Percentage of Participants
Interval 9.3 to 36.5
|
—
|
PRIMARY outcome
Timeframe: Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016Population: The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.
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 was presented for the first course of pembrolizumab treatment per protocol.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=132 Participants
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.
|
Cohort B: Head & Neck Cancer
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.
|
Cohort C: Urothelial Cancer
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.
|
Cohort D: Gastric Cancer
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2
|
18.2 Percentage of Participants
Interval 12.0 to 25.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016Population: The population consisted of all Cohort B and Cohort B2 HPV-positive participants who received ≥1 dose of study treatment.
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 was presented for the first course of pembrolizumab treatment per protocol.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=64 Participants
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.
|
Cohort B: Head & Neck Cancer
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.
|
Cohort C: Urothelial Cancer
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.
|
Cohort D: Gastric Cancer
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 Human Papilloma Virus (HPV)-Positive Participants
|
21.9 Percentage of Participants
Interval 12.5 to 34.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016Population: The population consisted of all Cohort D participants from AP region who received ≥1 dose of study treatment.
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 was presented for the first course of pembrolizumab treatment per protocol.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=19 Participants
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.
|
Cohort B: Head & Neck Cancer
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.
|
Cohort C: Urothelial Cancer
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.
|
Cohort D: Gastric Cancer
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants
|
21.1 Percentage of Participants
Interval 6.1 to 45.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016Population: The population consisted of all Cohort B or B2 participants who progressed following cetuximab and platinum therapy and received ≥1 dose of study treatment.
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 was presented for the first course of pembrolizumab treatment per protocol.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=110 Participants
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.
|
Cohort B: Head & Neck Cancer
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.
|
Cohort C: Urothelial Cancer
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.
|
Cohort D: Gastric Cancer
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 RECIST 1.1 Response Rate Based on BICR Review, for Participants Previously Treated With Cetuximab and Platinum in Cohorts B and B2
|
14.5 Percentage of Participants
Interval 8.5 to 22.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)Population: The population consisted of all Cohort A, B, C and D participants who received ≥1 dose of study treatment.
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 percentage of participants who experienced a CR or PR in Cohorts A, B, C and D based on investigator assessment was presented for the first course of pembrolizumab treatment per protocol. ORR per RECIST 1.1 based on investigator assessment was presented for Cohort B2 in a separate outcome measure.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=32 Participants
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.
|
Cohort B: Head & Neck Cancer
n=60 Participants
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.
|
Cohort C: Urothelial Cancer
n=33 Participants
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.
|
Cohort D: Gastric Cancer
n=39 Participants
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D
|
15.6 Percentage of Participants
Interval 5.3 to 32.8
|
16.7 Percentage of Participants
Interval 8.3 to 28.5
|
21.2 Percentage of Participants
Interval 9.0 to 38.9
|
33.3 Percentage of Participants
Interval 19.1 to 50.2
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression (Up to ~ 35 months) - through FA cutoff date 26 Apr 2016Population: The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.
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 percentage of participants who experienced a CR or PR in Cohort B2 based on investigator assessment was presented for the first course of pembrolizumab treatment per protocol. ORR per RECIST 1.1 based on investigator assessment was presented for the other cohorts in a separate outcome measure.
Outcome measures
| Measure |
Cohort A: Triple Negative Breast Cancer
n=132 Participants
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.
|
Cohort B: Head & Neck Cancer
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.
|
Cohort C: Urothelial Cancer
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.
|
Cohort D: Gastric Cancer
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.
|
Cohort B2: Head & Neck Cancer Expansion
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 RECIST 1.1 Response Rate Based on Investigator Assessment for Cohort B2
|
20.5 Percentage of Participants
Interval 13.9 to 28.3
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 8Population: The population was to consist of all allocated 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: Triple Negative Breast Cancer
Serious events: 13 serious events
Other events: 31 other events
Deaths: 25 deaths
Cohort B: Head & Neck Cancer
Serious events: 27 serious events
Other events: 58 other events
Deaths: 54 deaths
Cohort C: Urothelial Cancer
Serious events: 21 serious events
Other events: 32 other events
Deaths: 29 deaths
Cohort D: Gastric Cancer
Serious events: 17 serious events
Other events: 37 other events
Deaths: 34 deaths
Cohort B2: Head & Neck Cancer Expansion
Serious events: 60 serious events
Other events: 124 other events
Deaths: 110 deaths
Serious adverse events
| Measure |
Cohort A: Triple Negative Breast Cancer
n=32 participants at risk
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.
|
Cohort B: Head & Neck Cancer
n=60 participants at risk
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.
|
Cohort C: Urothelial Cancer
n=33 participants at risk
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.
|
Cohort D: Gastric Cancer
n=39 participants at risk
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.
|
Cohort B2: Head & Neck Cancer Expansion
n=132 participants at risk
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.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Cardiac disorders
Pericardial effusion
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Eye disorders
Vision blurred
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Oesophagitis
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Death
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
4/132 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Face oedema
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Fatigue
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Localised oedema
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Malaise
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Oedema peripheral
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Swelling face
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Fascial infection
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Infection
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Meningitis aseptic
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Otitis media
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
8.3%
5/60 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Sepsis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Injury, poisoning and procedural complications
Head injury
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Injury, poisoning and procedural complications
Osteoradionecrosis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
3.1%
1/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Blood fibrinogen decreased
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peripheral vascular system
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to rectum
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Drug withdrawal convulsions
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Vascular disorders
Embolism
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Seizure
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Syncope
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Product Issues
Device dislocation
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Product Issues
Device malfunction
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.8%
5/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Vascular disorders
Hypotension
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
Other adverse events
| Measure |
Cohort A: Triple Negative Breast Cancer
n=32 participants at risk
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.
|
Cohort B: Head & Neck Cancer
n=60 participants at risk
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.
|
Cohort C: Urothelial Cancer
n=33 participants at risk
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.
|
Cohort D: Gastric Cancer
n=39 participants at risk
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.
|
Cohort B2: Head & Neck Cancer Expansion
n=132 participants at risk
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.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.4%
3/32 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
31.7%
19/60 • Number of events 22 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
21.2%
7/33 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
20.5%
27/132 • Number of events 32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.1%
1/32 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
8.3%
5/60 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
1/32 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.8%
5/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Endocrine disorders
Hypothyroidism
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.0%
9/60 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
12.8%
5/39 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
14.4%
19/132 • Number of events 20 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.4%
3/32 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
18.2%
6/33 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
33.3%
13/39 • Number of events 16 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
8/132 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
6/32 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
25.0%
15/60 • Number of events 17 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
30.3%
10/33 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
17.9%
7/39 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.9%
21/132 • Number of events 22 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.1%
9/32 • Number of events 14 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
21.7%
13/60 • Number of events 20 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
12.8%
5/39 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.6%
14/132 • Number of events 16 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
4/132 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.0%
6/60 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
12.1%
16/132 • Number of events 16 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Nausea
|
28.1%
9/32 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
25.0%
15/60 • Number of events 21 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
27.3%
9/33 • Number of events 12 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
28.2%
11/39 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.2%
20/132 • Number of events 21 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
8.3%
5/60 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
4.5%
6/132 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
6/32 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
20.0%
12/60 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
18.2%
6/33 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
23.1%
9/39 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.8%
13/132 • Number of events 14 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Asthenia
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.8%
5/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Chest pain
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.8%
9/132 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Chills
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
8.3%
5/60 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.6%
10/132 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Face oedema
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Fatigue
|
53.1%
17/32 • Number of events 21 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
53.3%
32/60 • Number of events 35 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
51.5%
17/33 • Number of events 19 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
30.8%
12/39 • Number of events 15 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
44.7%
59/132 • Number of events 64 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Malaise
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Oedema peripheral
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
11.7%
7/60 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
33.3%
11/33 • Number of events 14 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Pain
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.8%
5/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Pyrexia
|
9.4%
3/32 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
20.0%
12/60 • Number of events 15 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
27.3%
9/33 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
16.7%
22/132 • Number of events 25 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Swelling face
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
8/132 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
General disorders
Temperature intolerance
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Candida infection
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
4/132 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
8/132 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Skin infection
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.8%
5/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
3/32 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
18.2%
6/33 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
4/32 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
4/32 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
4.5%
6/132 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Amylase increased
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
15.6%
5/32 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
12.1%
4/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
12.8%
5/39 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
8/132 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.8%
5/132 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Blood bilirubin increased
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Blood creatinine increased
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
27.3%
9/33 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
4/132 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
8/132 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Platelet count decreased
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Weight decreased
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
16.7%
10/60 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.4%
6/39 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
18.9%
25/132 • Number of events 32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Investigations
Weight increased
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.8%
5/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
23.3%
14/60 • Number of events 14 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
39.4%
13/33 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
30.8%
12/39 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
22.7%
30/132 • Number of events 31 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.0%
6/60 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.8%
9/132 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
11.7%
7/60 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
8/132 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
11.7%
7/60 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
4.5%
6/132 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
8.3%
5/60 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
8/132 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
18.3%
11/60 • Number of events 25 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.6%
10/132 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
8.3%
5/60 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
8/132 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
16.7%
10/60 • Number of events 18 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.2%
5/33 • Number of events 12 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
12/132 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.0%
6/60 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 12 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
8/32 • Number of events 12 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
18.3%
11/60 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.4%
6/39 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
12.1%
16/132 • Number of events 21 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
6/32 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.0%
9/60 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
18.2%
6/33 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.8%
13/132 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
12.1%
4/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
21.9%
7/32 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
11.7%
7/60 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
8.3%
5/60 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
31.2%
10/32 • Number of events 12 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
13.3%
8/60 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.7%
4/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.8%
13/132 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
4/32 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
4.5%
6/132 • Number of events 8 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.76%
1/132 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Balance disorder
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
16.7%
10/60 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.3%
4/39 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Headache
|
9.4%
3/32 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
16.7%
10/60 • Number of events 12 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.8%
13/132 • Number of events 15 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Psychiatric disorders
Anxiety
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.0%
6/60 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.8%
5/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Psychiatric disorders
Confusional state
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
12.1%
4/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Psychiatric disorders
Depression
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
4.5%
6/132 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Psychiatric disorders
Insomnia
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
8.3%
5/60 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.8%
9/132 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.6%
5/32 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.0%
9/60 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
20.5%
8/39 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.9%
21/132 • Number of events 24 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.9%
7/32 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
21.7%
13/60 • Number of events 15 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
21.2%
7/33 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.9%
21/132 • Number of events 21 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.0%
6/60 • Number of events 10 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
4/132 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
4/32 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.3%
3/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.0%
6/60 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
4.5%
6/132 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.0%
3/60 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.4%
3/32 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/132 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
2/32 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
12/132 • Number of events 14 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
2/32 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
7.7%
3/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.3%
2/60 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
4.5%
6/132 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
4/32 • Number of events 5 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
13.3%
8/60 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 4 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
15.4%
6/39 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
10.6%
14/132 • Number of events 15 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
4/32 • Number of events 6 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
18.3%
11/60 • Number of events 13 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
6.1%
2/33 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
13.6%
18/132 • Number of events 22 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/60 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
3.0%
1/33 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/39 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 9 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/32 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.7%
1/60 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
0.00%
0/33 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.1%
2/39 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
1.5%
2/132 • Number of events 2 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
16.7%
10/60 • Number of events 11 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
9.1%
3/33 • Number of events 3 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
2.6%
1/39 • Number of events 1 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
5.3%
7/132 • Number of events 7 • Serious and non-serious AEs were collected up to ~ 71 months and all-cause mortality up to ~ 85 months for pembrolizumab first and second course treatment (through end of trial (EOT) cutoff date 30 June 2020).
All-cause mortality was reported on all allocated participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Progressive Disease' and 'Malignant Neoplasm Progression' not related to the drug were excluded.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER